| WUSS |
2026 |
From Raw to Compliant: Applying Domain-Specific SAS Macros for Data Cut-Off in Clinical Trials |
Ballari Sen |
source |
26 |
| WUSS |
2026 |
Speeding Up Your Validation Process is As Easy As 1, 2 and 3 |
Alice M. Cheng |
source |
23 |
| PharmaSUG CN |
2026 |
A Standardized Programming Framework for Daily Dose Dataset Construction from Multi-Source Clinical Data |
Xianjun Li,
Chengye Lu |
source |
10 |
| PharmaSUG CN |
2026 |
ADICE: A Proposed ADaM Dataset Structure for Intercurrent Events in the Estimand Framework |
Lijie Zhu |
source |
11 |
| PharmaSUG CN |
2026 |
Clarity: An AI-Powered Shiny Application for Natural Language-Driven Clinical Data Analysis |
Jinzhi Zhou,
Yusi Liu,
Dan Su,
Jie Liu |
source |
14 |
| PharmaSUG CN |
2026 |
Designing an ADaM Dataset for Streamlined Drug-Induced Liver Injury Screening Analyses |
Ben Gao,
Danfeng Fu,
Guowei Wu |
source |
16 |
| PharmaSUG CN |
2026 |
From SAP to TFL: An AI-Assisted Workflow Framework for Automated Shells and TFLs |
Xiaoyu Ding,
Guoqing Zhao,
Huafeng Gao,
Zhiyuan Guo |
source |
18 |
| PharmaSUG CN |
2026 |
Modernizing the Vaccine TAUG: An End-to-End, Output-Driven Framework for Reactogenicity, Immunogenicity, Efficacy, and Reviewer-Ready Submissions |
Lin Chen,
Jialiang Liu |
source |
18 |
| PharmaSUG CN |
2026 |
Safety Estimands and Analysis Dataset Design: Advancing Safety Evaluation in Clinical Trials |
Kun Ren,
Zeyu Guang |
source |
11 |
| PharmaSUG |
2026 |
A Human-in-the-Loop AI-Assisted Framework for ADaM Standardization |
Chunqiu Xia,
Feiyang Du |
source |
12 |
| PharmaSUG |
2026 |
ADaM Pet Peeves Part 2: More Things Programmers Do That Make Us Crazy |
Sandra Minjoe,
Nancy Brucken,
Alyssa Wittle,
Nate Freimark,
Richann J. Watson,
Paul K. Slagle,
Tatiana Sotingco |
source |
15 |
| PharmaSUG |
2026 |
AI-Driven Intelligent Platforms for ADaM Specification and Code: Empowering Clinical Data Analysis |
Tingting Zeng,
Jia He,
Yaohui Zhu,
Shuang Gao,
Jinling Li,
Nana Yang |
source |
11 |
| PharmaSUG |
2026 |
AI-Powered Multiple-Agent Pipeline for Automating ADaM Dataset Generation |
Lucas Liu,
Bo Ci |
source |
5 |
| PharmaSUG |
2026 |
An End-to-End R-Based Pharmacokinetics (PK) Workflow for Regulatory Submission: The INAVO120 Study |
Qi Liu,
Shweta Vadhavkar |
source |
5 |
| PharmaSUG |
2026 |
ARMed AutoTable Macro Agents: An ARM-Driven Framework for Automated Analysis Table Generation |
Chengxin Li |
source |
10 |
| PharmaSUG |
2026 |
Automated Quality Checks for SDTM and ADaM Datasets Using R Shiny |
Shih-Che (Danny) Hsu,
Wei Qian |
source |
4 |
| PharmaSUG |
2026 |
Building ADaM Datasets from Scratch using R: A SAS programmer-s Perspective |
Patel Mukesh,
Nilesh Patel |
source |
15 |
| PharmaSUG |
2026 |
Closing the Expectation Gap: A Leadership Framework for Clinical Programming Success |
Yuka Tanaka-Chambers |
source |
14 |
| PharmaSUG |
2026 |
Dynamic Patient Profile Plot Development with SAS Graph Template Language |
Raghava Pamulapati,
Guowei Wu,
Danfeng Fu |
source |
13 |
| PharmaSUG |
2026 |
Early Restricted Unblinded PK Data Access (ERUPA): Framework to Accelerate PopPK and ERES Deliverables Through Data-Centric, Firewalled Workflows |
Dheeraj Rupani,
Srinivas Bachina,
Kiran Kumar Kode |
source |
7 |
| PharmaSUG |
2026 |
Early Unblinding to Pharmacometrics (PMx) Data: Challenges, Practices, and Benefits |
Shweta Vadhavkar,
Jing Su |
source |
6 |
| PharmaSUG |
2026 |
Enhancing ADaM Specification Validation and Generation of SAS Codes Using LLM through Amazon Bedrock: A Practical Framework |
Pavan Kumar Tatikonda,
Ryo Nakaya,
Sravan Kongara |
source |
10 |
| PharmaSUG |
2026 |
Enhancing CDISC Standards Implementation (SDTM and ADaM) with PROC FCMP, PROC IML and Macro Loop Integration in Oncology Clinical Trials. |
Ajay Gupta,
Misikir Tesfaye |
source |
7 |
| PharmaSUG |
2026 |
Following Your Footsteps: Maintaining Traceability in ADaM Datasets [presentation] |
Nancy Brucken,
Karl Miller |
source |
59 |
| PharmaSUG |
2026 |
Friction to Flow: LLM-Based Automation of Clinical Data Workflows |
Pankaj Attri,
Matthew J. Becker |
source |
8 |
| PharmaSUG |
2026 |
From Static to Dynamic: Leveraging R Shiny for Tumor Response Data Review |
Reneta Hermiz,
Jing Ji,
Amrit Pradhan,
Martin Sandel |
source |
10 |
| PharmaSUG |
2026 |
From Suspicion to Evidence: Automating Character Truncation Risk Audits with a Parameterized SAS Macro and Review-Ready Excel Output |
Xinran Hu |
source |
7 |
| PharmaSUG |
2026 |
Goodbye SAS, Hello R: Practical Workflows for CDISC Standards |
Madeleine Penniston,
Alyssa M. Wittle |
source |
12 |
| PharmaSUG |
2026 |
Human Beings Still Needed: Manual ADaM Checks that AI Can-t Do |
Sandra Minjoe,
Mario Widel |
source |
9 |
| PharmaSUG |
2026 |
Lessons to Guardrails: Operationalizing Early Checks for FDA Submission Readiness |
Jeff Xia |
source |
6 |
| PharmaSUG |
2026 |
Navigating Early Career Challenges in PK/ADA Statistical Programming |
Diyu Yang,
Sandeep Meesala |
source |
11 |
| PharmaSUG |
2026 |
Oncology Solid Tumor Subcutaneous vs Intravenous Late-stage Study Analysis |
Sumanjali Mangalarapu,
Chuqing Chen,
Anilkumar Anksapur |
source |
11 |
| PharmaSUG |
2026 |
One Study, Many Regulators: Submission-Ready Data Package for Multi-Region Filings |
Himanshu Patel,
Chintan Pandya |
source |
10 |
| PharmaSUG |
2026 |
One Word Can Make All the Difference(s): Strengthening Validation Practices with PROC COMPARE |
John M. LaBore,
Joshua M. Horstman |
source |
5 |
| PharmaSUG |
2026 |
Optimizing Clinical TFL Review with Python and Power BI: A Reproducible Workflow to Reduce QC Time and Improve Traceability |
Vijaya Lakshmi Cherakam,
Latha Donapati |
source |
10 |
| PharmaSUG |
2026 |
Programming Challenges in Developing PRO Analysis Datasets Under FDA's New Submission Guidance |
Weiwei Guo,
Caizhi Huang |
source |
10 |
| PharmaSUG |
2026 |
SAS and R for Expanding Data for Pharmacometrics Analysis (PMx) Analysis Data Sets |
Jeffrey Rathbun,
Rebecca Humphrey |
source |
8 |
| PharmaSUG |
2026 |
Speeding Up Your Validation Process is As Easy As 1, 2 and 3 |
Alice M. Cheng |
source |
19 |
| PharmaSUG |
2026 |
Two Paths, One PK Journey: The Art of Balancing ADPC and ADNCA |
Ashok Abburi,
Rakhe Jacob,
Shibani Harite |
source |
7 |
| PHUSE US |
2026 |
Accelerating Study Insights: Agile Data Visualisation Using R-Shiny |
Lin Yuan,
Heather Howell |
source
presentation source |
6 |
| PHUSE US |
2026 |
Advancing Precision Medicine and Regulatory Readiness: Data Harmonisation and Statistical Methods for Companion Diagnostics Bridging Studies |
Ummul Vara Qurratul Ain |
source
presentation source |
10 |
| PHUSE US |
2026 |
AI-Powered Multiple-Agent Pipeline for Automating ADaM Dataset Generation |
Bo Ci |
source
presentation source |
4 |
| PHUSE US |
2026 |
Around the Data DOSE-y Doe: Using DOSExx Variables within ADaM Datasets |
Inka Leprince,
Richann J. Watson |
source |
10 |
| PHUSE US |
2026 |
AUTOCODE: Metadata-Driven Automation for Faster, Traceable SDTM and ADaM Programming |
Matthew Finnemeyer |
source
presentation source |
6 |
| PHUSE US |
2026 |
Automated Code Generation: Evaluating Deterministic and Probabilistic Approaches |
Malan Bosman |
source
presentation source |
6 |
| PHUSE US |
2026 |
Automated Programming Consistency Checks: Enhancing Clinical Programming Quality, Efficiency and Scalability |
Narendra Babu Kolisetty |
source
presentation source |
5 |
| PHUSE US |
2026 |
Beyond Box-Checking: Five Best Practices for Embedding QC in Modern SCEs |
Chris McSpiritt |
source
presentation source |
6 |
| PHUSE US |
2026 |
Breaking Free from the xpt: Exploration of Dataset-JSON as an Alternative Transport File to Regulatory Agencies |
Benjamin Straub,
Samir Parmar |
source
presentation source |
8 |
| PHUSE US |
2026 |
Common Issues in BIMO Clinical Site Dataset Packages |
Michael Beers |
source
presentation source |
7 |
| PHUSE US |
2026 |
Data Harmonisation for ISS and ISE: A Practical Checklist for Integration Success |
Qiong Wei,
Lily Cheng |
source
presentation source |
10 |
| PHUSE US |
2026 |
Demonstrations of AutoTable |
Chengxin Li |
source
presentation source |
11 |
| PHUSE US |
2026 |
Development Process of the Bioresearch Monitoring (BIMO) Package and the Obstacles Successfully Addressed [presentation] |
Sarad Nepal,
Murali Neela |
source |
19 |
| PHUSE US |
2026 |
Electronic Clinical Data Submissions Across Global Regulatory Authorities |
Sampath Madanu |
source
presentation source |
12 |
| PHUSE US |
2026 |
Electronic Submission of Population PK Analysis Files ... What's Your Modus Operandi? |
Luai R. Alzoubi |
source
presentation source |
13 |
| PHUSE US |
2026 |
End-to-End Workflow for CDISC Estimand Framework in Clinical Trials |
Hiral Raval,
Simon Luo |
source
poster source |
12 |
| PHUSE US |
2026 |
Ensuring Reliability of Medical Devices Through Statistical Oversight in the Age of AI |
Parvee Kumar,
Shrutimita Pokhariyal |
source
presentation source |
11 |
| PHUSE US |
2026 |
From ATC to ACG: Implementing the Concomitant Medication Grouping (ACG) Dataset in Clinical Trial Analysis |
Michelle Starkell |
source
presentation source |
8 |
| PHUSE US |
2026 |
From Legacy to ISS/ISE: Real-World Lessons in Module 5 Submissions |
Ajay Gunda,
Kishore Pothuri |
source
presentation source |
5 |
| PHUSE US |
2026 |
From SAS to R for TLGs: A Case Study on Implementing an 'R-First, SAS-QC' Workflow for Time-to-Event Analysis |
Adler Moisés Fallas Rodríguez |
source
presentation source |
8 |
| PHUSE US |
2026 |
Group, Collapse, Repeat: A Dynamic SAS Macro for Stratification Pooling in Oncology Efficacy Analysis |
Venkatesh Burla |
source
presentation source |
9 |
| PHUSE US |
2026 |
Harmonising gsm and the pharmaverse: Orchestrating SDTM, ADaM, TFLs and ARS in a Unified R Workflow |
Zelos Zhu |
source
presentation source |
3 |
| PHUSE US |
2026 |
Harnessing LLM-Augmented Automation for ADaM Dataset Generation |
Anil Mogha,
Ghourav Garg |
source
presentation source |
9 |
| PHUSE US |
2026 |
Interactive and Instant: GenAI-Driven Creation of Clinical Trial Applications |
Marcin Dubel |
source
presentation source |
12 |
| PHUSE US |
2026 |
Key Guidelines, Tricks and Experiences for the PMDA and a Comparison with FDA and NMPA CDE Submissions |
Ramesh Potluri |
source
presentation source |
5 |
| PHUSE US |
2026 |
LLM-Powered Clinical Data Flow with Traceability - From Siloed Pipelines to a Semantic Fabric |
Pankaj Attri,
Matthew J. Becker |
source
presentation source |
8 |
| PHUSE US |
2026 |
Metadata-Driven TFL Generation: End-to-End Automation from Protocol to Output |
Bill Qubeck |
source
presentation source |
12 |
| PHUSE US |
2026 |
Next Generation QC Workflow Optimisation: Current Practices and Future Directions from the Emerging Trends & Innovation Working Group |
Matthew Finnemeyer,
Caroline Phares |
source
presentation source |
13 |
| PHUSE US |
2026 |
One eye open, one eye closed: How to approach masking in open-label oncology study |
Abhay Kumar |
source
presentation source |
8 |
| PHUSE US |
2026 |
Open Source as a Strategic Enabler for EMA Submissions: An R Shiny Approach |
Marckenley Mercie |
source
presentation source |
5 |
| PHUSE US |
2026 |
QC Without Code: ChatGPT Enterprise for Sponsor Oversight of Outsourced TFLs |
Jenny Price,
Brad Moore |
source
presentation source |
9 |
| PHUSE US |
2026 |
Real-Time AI-Driven TLF Generation with GAutoTLF |
Hao Xu,
Tyler Rowsell |
source
presentation source |
14 |
| PHUSE US |
2026 |
Real-World Evidence Pavilion: Interactive Workshop: Bridging Estimands & Target Trial Emulation [presentation] |
Lauren Dang,
Matt Baldwin |
source |
6 |
| PHUSE US |
2026 |
Redefining Quality: Transforming Internal Reviews into Team Development Tools |
Arman Melkonyan |
source
presentation source |
10 |
| PHUSE US |
2026 |
SCE White Paper 2.0 - A Modernised Framework for the Next Generation of Data Analysis |
Mark Bynens |
source
presentation source |
7 |
| PHUSE US |
2026 |
SpecToSAS: AI-Powered SAS Code Generation from Study Specs |
Gargee Vaidya,
Lluis Gimenez |
source
presentation source |
12 |
| PHUSE US |
2026 |
Standardising Exposure-Response Data for Modelling and Simulation Using CDISC Principles and {admiral} |
Jeffrey Dickinson |
source
presentation source |
12 |
| PHUSE US |
2026 |
Statistical Programming Methods for Evaluating the Impact of Immunogenicity on Safety and Efficacy Outcomes |
Dinesh Putluri,
Rakesh Padigala |
source
presentation source |
10 |
| PHUSE US |
2026 |
Submitting RWD: Where We Are and Where We Are Going |
Ingeborg Holt,
Sarah Ferko,
Jeffrey M. Abolafia |
source
presentation source |
24 |
| PHUSE US |
2026 |
Time to Roclet! admiral's use of custom roclets to enhance and extend examples in function documentation |
Benjamin Straub |
source
presentation source |
9 |
| PHUSE US |
2026 |
Transforming Legacy Data into CDISC Standards: Practical Approaches and Regulatory Insights |
Khalif Halani,
Veena Palle |
source
presentation source |
6 |
| PHUSE US |
2026 |
Utilizing AI for Automated Conversion of ADaM Specifications to R Code |
Alice Ehmann,
Kjersten Offenbecker |
source
presentation source |
9 |
| PHUSE US |
2026 |
Validating AI in GxP: Test Harnesses, Guardrails and Compliance Controls |
Bill Qubeck |
source
presentation source |
14 |
| PHUSE US |
2026 |
Visualising Essential Metrics for Assessing Disease Dynamics in Hematologic Oncology Trials: A SAS Graphic Approach |
Jiashan Li |
source
presentation source |
8 |
| PHUSE US |
2026 |
What Pharma Can Learn from Data Science Outside the Industry |
Kris Wenzel,
Liz Cole |
source
presentation source |
11 |
| PHUSE APAC |
2026 |
AI for Adverse Event Signal Detection: Moving Beyond |
Monika Monika |
source
presentation source |
10 |
| PHUSE APAC |
2026 |
Automating TFL Generation Using R and pharmaRTF: From Data to Submission-Ready TFLs |
Dhananjay Srivastava |
source |
4 |
| PHUSE APAC |
2026 |
Batch Execution of CDISC SDTM/ADaM Programs with R |
Batch Execution,
Denny Sebastian,
Mohin K Mohanan |
source
presentation source |
8 |
| PHUSE APAC |
2026 |
Beyond Code: Elevating NextGen Statistical Programmers through Cross-Functional Learnings |
Saumil Tripathi |
source
presentation source |
7 |
| PHUSE APAC |
2026 |
Charting New Territory: R-Based Submissions Made Easy |
Veena Terekar |
source
presentation source |
7 |
| PHUSE APAC |
2026 |
E2E Clinical Metadata Journey: 'Single Source of Truth' to Accelerate Clinical Research - From Collection and Tabulation to Analysis and Reporting |
Indumathi Narasetty |
source
presentation source |
9 |
| PHUSE APAC |
2026 |
Elevating transparency in data standardization Applying XAI in SDTM, ADaM, and TLF Generation |
Shakila Jagadeesan |
source
presentation source |
10 |
| PHUSE APAC |
2026 |
End-to-End Continuous Integration and Deployment Pipeline for Multi Language Analytics Applications: A Clinical Data Management Case Study |
Avinash Patnaik,
Varun Sethuraman |
source
presentation source |
7 |
| PHUSE APAC |
2026 |
Enhancing Real-Time Clinical Reporting with R Shiny and Large Language Models: Automated Code Generation and Dynamic TLG Visualization |
Mahesh Divakaran |
source
presentation source |
10 |
| PHUSE APAC |
2026 |
Implementation of the ICH E9(R1) Estimands Framework Using Data Standards [presentation] |
Shahida Tamboli |
source |
26 |
| PHUSE APAC |
2026 |
Internal Paper AS19 Time-to-Event Analysis in Pain Management: A Case Study of the Double Stopwatch Method and ADaM Dataset Development in Relation to Rescue Medication |
Arnode Mukherjee,
Abhishek Paul |
source
presentation source |
12 |
| PHUSE APAC |
2026 |
TFL Automation Through Design, Specify, Execute, and Report: A Seamless End-to-End Framework |
Malan Bosman,
Bhavin Busa |
source
presentation source |
8 |
| PHUSE APAC |
2026 |
Unified Meta-Study: Harmonizing Clinical Biomarker, Genomics and Clinical Trial Data for enhanced access, usability, and lifecycle management |
Namrata Padmashali |
source
presentation source |
3 |
| PHUSE EU |
2025 |
ADaM Conformance Rules: Bridging the Gap Between Standards and Practice |
Rafik Ghazaryan |
source
presentation source |
6 |
| PHUSE EU |
2025 |
Automated QC Framework for Reliable ADNCA Dataset Generation with {admiral} |
Valentin Legras,
Lucy Aspridis |
source
presentation source |
4 |
| PHUSE EU |
2025 |
Bridging the Gap: Translating Intercurrent Events into Analysis-Ready ADaM Datasets |
Meghna Diedrich |
source
poster source |
9 |
| PHUSE EU |
2025 |
But Wait, There's More: When RECIST 1.1 Is Not Enough |
Anny Yamileth Olivares Mundo |
source
poster source |
8 |
| PHUSE EU |
2025 |
Digital SAP Model Using Biomedical Concepts |
Tom Ratford |
source
presentation source |
5 |
| PHUSE EU |
2025 |
Efficient Conversion of SDTM/ADaM Specifications from Excel to Define-XML v2.1 Using Pinnacle 21 Community |
Hiromi Okada,
Seiko Yamazaki |
source
presentation source |
15 |
| PHUSE EU |
2025 |
End-to-End R: Where To Start? |
Luke Thompson |
source
presentation source |
6 |
| PHUSE EU |
2025 |
From Static Archives to Analytical Intelligence: Transforming Statistical Analysis Value Through Standardization |
Ilan Carmeli |
source
presentation source |
8 |
| PHUSE EU |
2025 |
IDD'AI: Automating the Tedious So You Can Focus on the Genius |
Lionel Debecq,
Samantha Cambier |
source
presentation source |
8 |
| PHUSE EU |
2025 |
Implementing ADNCA in the PK Process: A Cross-Departmental Approach |
Daphne Vuurstaek,
Frédéric Saad |
source
poster source |
4 |
| PHUSE EU |
2025 |
Leveraging AI for Seamless SAS to R Migration: Challenges and Opportunities |
Milena Kraus,
Corrina Stoeckinger |
source
presentation source |
11 |
| PHUSE EU |
2025 |
Mind the Gap: Imputing Missing Dosing Times in QD & BID Regimens Using ADPPK Guidelines |
Aschwin van der Giesen,
Gerly van der Vleuten |
source
presentation source |
8 |
| PHUSE EU |
2025 |
More Science, Less Bookkeeping: Our Path to Hyper-Efficient ADaM Program Generation via AI, Process Improvements, and Good Old-Fashioned Programming |
Matthew Phelps,
Nicolai Skov Johnse |
source
presentation source |
10 |
| PHUSE EU |
2025 |
Multiple Imputations Overview of Missing Data Problem, Solution Methods and SAS Implementation |
Dmytro Kalinin |
source
presentation source |
13 |
| PHUSE EU |
2025 |
Our Journey in Integrating External Control Arms (ECAs) and Real-World Data (RWD) for Rare Disease Trials |
Cyril Sombrin,
Gautham Selvaraj |
source
poster source |
4 |
| PHUSE EU |
2025 |
Qualitative ADaM Datasets and Define-XML Without Using ADaM Specs |
Pieter Coppens |
source
presentation source |
4 |
| PHUSE EU |
2025 |
Reproducibility, Lineage and Control: Building a Traceability Framework for the Modern Clinical Trial |
Bill Qubeck,
Shilpa Sood |
source
poster source |
6 |
| PHUSE EU |
2025 |
Robust Programming Strategies for Exposure to ADaM Datasets |
Susann Grill |
source
poster source |
13 |
| PHUSE EU |
2025 |
Snakemake for Statistical Programmers: Automation and Reproducibility in Clinical Studies |
Nassim Sleiman,
Mathieu Cayssol |
source
poster source |
11 |
| PHUSE EU |
2025 |
Statistical Endpoints and Analysis in Diagnostic Imaging: The Matrix Has You and Your Data |
Srinivas Lanka,
James Sykes |
source
presentation source |
17 |
| PHUSE EU |
2025 |
The Chicken, the Egg and the ADaM: Cracking the PRE-ADSL vs ADSL Sequence |
Carla Santillán,
Dubravka Georgijevic |
source
presentation source |
8 |
| PHUSE EU |
2025 |
Think like a Quarterback - Deliver Projects, not fumbles |
Eoin Byrne |
source
presentation source |
9 |
| PHUSE EU |
2025 |
Turbocharge Your Trials: Transform CRF Creation and the CDISC standardization process with Xbiom's Smart Metadata Repository and AI/ML Integrations |
Harinarayanan Gopichandran |
source
presentation source |
8 |
| PHUSE EU |
2025 |
Turning Data into Deliverables: Automating Biometrics from Metadata to TFLs |
Inderjeet Arora |
source
presentation source |
9 |
| PHUSE EU |
2025 |
Untangling the Dependencies Web |
Rhys McCrosson |
source
presentation source |
12 |
| PHUSE EU |
2025 |
{AdmiralMetabolic}: A Collaborative Journey To Develop an Admiral Extension Package for Metabolic Data |
Anders Askeland,
Olga Starostecka |
source
presentation source |
5 |
| MWSUG |
2025 |
Advancing Research in Rare Disease Using SAS Viya [presentation] |
Kelly Olano,
Pierce Kuhnell,
Laurie Smith |
source |
18 |
| MWSUG |
2025 |
Mind the Gaps: Automating Multiple Imputation in Clinical Trial Workflows [presentation] |
Crisa Chen,
Jiangang Cai |
source |
30 |
| SESUG |
2025 |
Enhance flexibility and variability by utilizing an Intermediate Dataset when developing the ADaM Efficacy Dataset in Vaccine Studies |
Edward Boykis |
|
6 |
| SESUG |
2025 |
Enhanced Reporting Traceability: An R Shiny Application for Live Dependency Tracking and SAS Code Execution |
Tongda Che,
Laura Frederick,
Peng Wan |
|
11 |
| SESUG |
2025 |
SAS and R in Action: Comparison of XPT File Creation |
Chen Ling |
|
7 |
| WUSS |
2025 |
Around the Data DOSE-y Doe, How Much Fun Can Your Data Can Be: Using DOSExx Variables within ADaM Data Sets |
Inka Leprince,
Richann J. Watson |
source |
13 |
| WUSS |
2025 |
PFS2, did you hear about it too? - Understanding the derivation of Progression Free Survival on next-line therapy (PFS2). |
Yeshashwini Chenna,
Lupetu Ntambwe |
source |
11 |
| PharmaSUG |
2025 |
ADaM Fundamental Principles vs. Rules: Which to Follow, When, and Why? |
Sandra Minjoe,
Mario Widel |
source |
6 |
| PharmaSUG |
2025 |
ADaM implementation for Anti-drug Antibody Data |
Jiannan Kang,
Luke Reinbolt |
source |
19 |
| PharmaSUG |
2025 |
ADaM Pet Peeves: Things Programmers Do That Make Us Crazy |
Sandra Minjoe,
Nancy Brucken |
source |
13 |
| PharmaSUG |
2025 |
Addressing early challenges in RWD data standardization for analysis and reporting of RWE studies |
Xingshu Zhu,
Li Ma,
Bo Zheng |
source |
9 |
| PharmaSUG |
2025 |
Approaches to Developing Multiple Imputation ADaM Datasets |
Kang Xie |
source |
8 |
| PharmaSUG |
2025 |
Automating Define-XML Updates: A SAS-Based Framework for Submission Readiness |
Qiong Wei,
Lixin Gao |
source |
10 |
| PharmaSUG |
2025 |
Automating Superscript Display for Upper and Lower Limit of Quantification Values in Pharmacodynamic Tables |
Anu Eldho |
source |
7 |
| PharmaSUG |
2025 |
Bridging the Gap: Leadership of Statistical Programmers in Clinical Trials |
Allison Covucci,
Xiaohan Zou |
source |
6 |
| PharmaSUG |
2025 |
Checking Outside the Box: A Framework for Submission Success |
Julie Ann Hood,
Seiko Yamazaki |
source |
13 |
| PharmaSUG |
2025 |
Common Issues in BIMO Clinical Site Dataset Packages |
Michael Beers |
source |
9 |
| PharmaSUG |
2025 |
Comparing SQL and Graph Database Query Methods for Answering Clinical Trial Questions with LLM-Powered Pipelines |
Jaime Yan |
source |
24 |
| PharmaSUG |
2025 |
Controlling attributes of .xpt files generated by R |
Yachen Wang,
Chen Ling |
source |
13 |
| PharmaSUG |
2025 |
Deciphering Exposure-Response Analysis Datasets: A Programmer-s Perspective for Oncology Studies |
Sabarinath Sundaram |
source |
6 |
| PharmaSUG |
2025 |
Decoding the Role of Statistical Programming - A Decade of Keytruda Submissions and Approvals |
Mary N. Varughese,
Hong Qi |
source |
8 |
| PharmaSUG |
2025 |
Efficacy Endpoints Related to CNS in Oncology Studies within ADaM |
Lihui Deng,
Kylie Fan |
source |
6 |
| PharmaSUG |
2025 |
Embracing an Extra Step as the Ultimate Shortcut: Leveraging ADDATES for Enhanced Efficiency and Traceability in Oncology Studies |
Chia-Lu Lee,
Wanchian Chen,
Anna Chen |
source |
6 |
| PharmaSUG |
2025 |
Exploring the Upcoming Integrated cSDRG! |
Srinivas Kovvuri,
Christine McNichol,
Randi McFarland,
Kiran Kumar Kundarapu,
Satheesh Avvaru |
source |
13 |
| PharmaSUG |
2025 |
Gen AI Assisted Code Conversion: From SAS to R Standard ADaM Templates |
Jeff Cheng,
Srinivas Malipeddi,
Gurubaran Veeravel,
Jaime Yan,
Suhas R. Sanjee |
source |
11 |
| PharmaSUG |
2025 |
Guidance from the FDA authored "Submitting Patient-Reported Outcome Data in Cancer Clinical Trials" and recommendations for their implementation in study CDISC COA data. |
Charity Quick |
source |
14 |
| PharmaSUG |
2025 |
Handling Health Regulatory Information Requests: Best Practices and Strategies |
Himanshu Patel,
Chintan Pandya |
source |
11 |
| PharmaSUG |
2025 |
Hands-on Training: eTFL Portal & TFL Designer Community |
Bhavin Busa |
source |
8 |
| PharmaSUG |
2025 |
Harnessing AI & CDISC ARS for Effortless Statistical Reporting & CSR Writing |
Bhavin Busa,
Navin Dedhia |
source |
10 |
| PharmaSUG |
2025 |
Identification of Domains Containing Screen Failure Participants in SDTMs and ADaMs for Reviewer-s Guides |
Sumanjali Mangalarapu |
source |
5 |
| PharmaSUG |
2025 |
Integrating SAS DDE to Automate Excel Task Tracking in Pharmaceutical Statistical Programming |
Amy Zhang,
Huei-Ling Chen |
source |
8 |
| PharmaSUG |
2025 |
Integration Contemplation: Considerations for a Successful ISS/ISE from Planning to Execution |
Jennifer McGrogan,
Mario Widel |
source |
8 |
| PharmaSUG |
2025 |
Key guidelines, Tricks and Experiences for PMDA and comparison with FDA and CDE submission |
Ramesh Potluri |
source |
6 |
| PharmaSUG |
2025 |
Leveraging Health Technology Assessment (HTA) for Market Access: A Statistical Programming Perspective on German HTA Submission |
Rachana Agarwal,
Wendy Wang |
source |
5 |
| PharmaSUG |
2025 |
Leveraging previous study data for Extension studies: Structuring Subject and Participant Level Analysis datasets using CRF data |
Priyanka Thumuganti |
source |
7 |
| PharmaSUG |
2025 |
Macro to Compare ADaM Spec Derivations Against Available SDTM Data |
Ingrid Shu,
Kexin Guan,
Jeff Xia |
source |
9 |
| PharmaSUG |
2025 |
Multiple Imputation Techniques in the Context of ADaM Datasets |
Shunbing Zhao,
Linping Li |
source |
11 |
| PharmaSUG |
2025 |
Name That ADaM Dataset Structure |
Nancy Brucken |
source |
8 |
| PharmaSUG |
2025 |
Programming Perspectives for Efficient and Accurate C-QTc Analysis |
Lingjie Zhang,
Lata Maganti,
Richard Moreton,
Runcheng Li |
source |
11 |
| PharmaSUG |
2025 |
Roadmap to Efficacy Analysis for Early Phase Oncology studies |
Dhruv Bansal,
Christiana Hawn,
Chris Kelly |
source |
23 |
| PharmaSUG |
2025 |
Sensitivity Analysis for Overall Survival |
Binal Mehta,
Patel Mukesh |
source |
13 |
| PharmaSUG |
2025 |
Streamlining Validation Review and SAS Program Management with R |
Huei-Ling Chen |
source |
11 |
| PharmaSUG |
2025 |
The Winding Road to ADSL |
Elizabeth Dennis,
Grace Fawcett |
source |
6 |
| PharmaSUG |
2025 |
The {teal} Adoption Playbook: Strategies, Tools, and Learning Paths for Open Source |
Vedha Viyash |
source |
8 |
| PharmaSUG |
2025 |
TLFQC: A High-compatible R Shiny based Platform for Automated and Codeless TLFs Generation and Validation |
Chen Ling,
Yachen Wang |
source |
18 |
| PharmaSUG |
2025 |
Transitioning External Clinical Studies to Internal: A Framework for Knowledge Transfer and Operational Excellence |
Chunqiu Xia,
Hong (Lily) Zhang,
Xiaohui Wang |
source |
6 |
| PharmaSUG |
2025 |
Updating Define-XML packages: Tips and A Comprehensive Checklist |
Qiong Wei,
Ji Qi,
Lixin Gao |
source |
10 |
| PharmaSUG |
2025 |
What comes first, the chicken (ADSL) or the egg (ADNCA)? Modularize your covariate creation to support flexible analysis dataset implementation! |
David C. Izard |
source |
6 |
| PharmaSUG |
2025 |
When PROC SORT Isn-t Enough: Implementing Horizontal Sorting in SAS |
Krutika Parvatikar,
Jeff Xia |
source |
5 |
| PharmaSUG |
2025 |
Which ADaM Data Structure Is Most Appropriate? Gray Areas in BDS and OCCDS. |
Veronica Gonzalez |
source |
15 |
| PHUSE US |
2025 |
A Novel Pipeline for Generating Realistic Synthetic CDISC ADaM Datasets Using Large Language Models and Knowledge Graphs |
Chao Su,
Jaime Yan |
source
presentation source |
15 |
| PHUSE US |
2025 |
Advancing TFL Automation: R-Based Meta-Programming Powered by ARS |
Malan Bosman |
source
presentation source |
7 |
| PHUSE US |
2025 |
An End-to-End Approach to Fine-Tuning Small LLMs for Generating Admiral R Code in Statistical Programming |
Tingting Tian,
Jaime Yan |
source
presentation source |
15 |
| PHUSE US |
2025 |
An Intuitive Way to Derive the Last Known Alive Date in R |
Marckenley Mercie,
Diana Tai |
source
presentation source |
12 |
| PHUSE US |
2025 |
Automating Preliminary CDISC SDTM Compliance Checks with a Customised SAS Macro |
Wei Qian,
Danny (Shih-Che) Hsu |
source
poster source |
3 |
| PHUSE US |
2025 |
Data Quality in Pooled Studies: Overcoming Challenges and Ensuring Accuracy |
Monika Ludwinska |
source
presentation source |
11 |
| PHUSE US |
2025 |
Double Trouble: Essential Insights from Successful Dual sBLA Submissions for a Drug-Device Combo |
Elma Ferdousy,
Aldrich Salva |
source
presentation source |
7 |
| PHUSE US |
2025 |
E2E R Submission from a Roche Oncology Study |
Jingyuan Chen,
Hinal Patel |
source
presentation source |
6 |
| PHUSE US |
2025 |
End-to-End Therapeutic Area Data Standards Development and Governance - A Case Study Involving CRS and ICANS |
Yaling Teng |
source
presentation source |
7 |
| PHUSE US |
2025 |
Enhancing Clinical Trial Data Queries with LLMs and Neo4j: A Flexible Framework for ADaM Dataset Management |
Jaime Yan |
source
presentation source |
28 |
| PHUSE US |
2025 |
From Roadblocks to Roadmaps: Overcoming Challenges in Registry Data Reporting |
Sivasankar Konda,
Neha Srivastava |
source
presentation source |
4 |
| PHUSE US |
2025 |
Gen-AI for Statistical Reporting and Clinical Study Report (CSR) Writing |
Leveraging CDISC |
source
presentation source |
10 |
| PHUSE US |
2025 |
Interactive Visualisation of Pooled Clinical Trial Safety Data |
Sara Bodach,
Ling Zhang |
source
presentation source |
7 |
| PHUSE US |
2025 |
Learning to skate, pedal, and drive - Change leadership in the world of Agile delivery |
Eileen Ching |
source
presentation source |
9 |
| PHUSE US |
2025 |
Management of Regulatory Submissions Using eCTD Sequences and Life Cycle Operators: Lessons from Real-Time Oncology Review (RTOR) and Regular Submissions |
Madhusudhan Reddy Papasani,
Elisabeth Pyle,
Mary N. Varughese |
source
presentation source |
8 |
| PHUSE US |
2025 |
Optimising SDTM and ADaM: Remediation Techniques for Data Accuracy |
Kishore Pothuri |
source
presentation source |
10 |
| PHUSE US |
2025 |
Optimizing Development and Regulatory Submission of eSUB Package for Exposure-Response and PK/PD Analysis |
Saumilkumar Tripathi,
Ephicacy Lifescience |
source
presentation source |
10 |
| PHUSE US |
2025 |
R Consortium's R-Based Test Submission Package for FDA Evaluation: A Milestone and a New Frontier in R-Based Regulatory Submissions |
Joel Laxamana |
source
poster source |
7 |
| PHUSE US |
2025 |
Redefining FDA Submissions: The Future of Interactive R Shiny Dashboards |
André Veríssimo,
Vedha Viyash |
source
presentation source |
5 |
| PHUSE US |
2025 |
SAS Programming approach for adjustment of treatment switching using Two-Stage Method |
Mani Mudumba |
source
presentation source |
13 |
| PHUSE US |
2025 |
Standardised and Automated Template for Dose Escalation Decision-Making |
Jasmina Uzunovic,
Aditi Qamra |
source
presentation source |
6 |
| PHUSE US |
2025 |
The Development of the CDISC eTFL Portal To Support the Adoption and Implementation of the Analysis Result Standard |
Bess LeRoy,
Bhavin Busa |
source
presentation source |
8 |
| PHUSE US |
2025 |
The Future of Data Surveillance in Clinical Studies: A Comprehensive Approach to Data Monitoring Using an R Shiny Application for Study Health |
Jacky Jin,
Ruchitbhai Patel |
source
presentation source |
5 |
| PHUSE US |
2025 |
The Implementation of {teal} Shiny Apps for DMC Activities |
Zhen Wu,
Peng Zhang |
source
presentation source |
7 |
| PHUSE US |
2025 |
Transforming Clinical Trials with AI-Driven Protocol Optimization and Next-Gen Statistical Programming |
Ravindra Shukla |
source
presentation source |
8 |
| PHUSE US |
2025 |
Turbocharge Your Trials: Transform CRF Creation and the CDISC standardization process with Xbiom's Smart Metadata Repository and AI/ML Integrations |
Harinarayanan Gopichandran |
source
presentation source |
8 |
| PHUSE US |
2025 |
Unlocking the Secrets of Health: A Unified Approach to Biomarker and Clinical Data Integration |
Pavan Kumar Tatikonda |
source
presentation source |
8 |
| PHUSE US |
2025 |
Unravelling the Complexity: Efficacy Datasets in Oncology Basket Trials Across Multiple Diseases |
Venkatesh Burla,
Manasa Ravi |
source
presentation source |
7 |
| PHUSE US |
2025 |
What's In a Message? Enhancing Error and Warning Messages for the Admiral R Package for ADaM Datasets |
Benjamin Straub,
Daniel Sjoberg |
source
presentation source |
8 |
| PHUSE US |
2025 |
Write Concise ADaM Programs with If-less Programming Techniques |
Wei Shao,
Lei Zhang |
source
presentation source |
17 |
| PHUSE EU |
2024 |
A way out of the PROC COMPARE labyrinth |
Judith Kanz |
source
poster source |
9 |
| PHUSE EU |
2024 |
ADRG Builder Python Application |
Pierre Dostie |
source
presentation source |
16 |
| PHUSE EU |
2024 |
Biomarkers Unleashed: A Programming Pipeline from Chaos to Clarity in Genomic Data |
Saskia Ständler,
Lea Zittlau |
source
presentation source |
10 |
| PHUSE EU |
2024 |
Data integration on CDISC ADaM Level: Multi-purpose Structures of ADSL and BDS Datasets |
Renate Scheiner-Sparna |
source
presentation source |
6 |
| PHUSE EU |
2024 |
Estimands: How to Make ADaM Implementation Your Friend |
Jaclyn Amberg |
source
presentation source |
10 |
| PHUSE EU |
2024 |
Harmonising FDA and PMDA Submission Requirements |
Luca Semeraro |
source
presentation source |
12 |
| PHUSE EU |
2024 |
How Agile Can you Be? Looking at Statistical Programming as a Software Development Process |
Oliver Wirtz,
Peter Bonata |
source
presentation source |
6 |
| PHUSE EU |
2024 |
ID-SPECTACKLE: Making ADaM specifications "Fun" |
Sophie Dekeyser |
source
presentation source |
11 |
| PHUSE EU |
2024 |
Incorporating Longitudinal Co-Medication Data into Population Pharmacokinetic (POPPK) Analysis Datasets: A Programmer's Perspective |
Aschwin van der Giesen,
Gerly van der Vleuten |
source
presentation source |
5 |
| PHUSE EU |
2024 |
Insights of Using {admiralonco} at BMS: Facilitating Oncology Efficacy ADaM Datasets |
Yirong Cao,
Yi Yan |
source
presentation source |
10 |
| PHUSE EU |
2024 |
Introduction to the ADNCA ADaM |
Charlotte Hampson,
Florence Horspole |
source
poster source |
4 |
| PHUSE EU |
2024 |
Lessons Learned From the ADaM Data Development Using ADMIRAL [poster] |
Katarzyna Golasa,
Tomasz Lebitko |
source |
1 |
| PHUSE EU |
2024 |
Making SDTM/ADaM CRT Packages Submission Ready |
Phillip Spowart |
source
presentation source |
10 |
| PHUSE EU |
2024 |
Navigating First Data Submission: Pierre Fabre's Journey and Insights into Data Submission Challenges with the NMPA |
Romain Raymond,
Benoit Sansas |
source
presentation source |
7 |
| PHUSE EU |
2024 |
Optimising Workflow and Collaboration in a Pooled Coding Environment for Clinical Development |
Louise Noergaard |
source
presentation source |
8 |
| PHUSE EU |
2024 |
Pre ADSL - Revolutionise Your ADaM Workflow |
Korak Datta,
Taniya Chatterjee |
source
presentation source |
8 |
| PHUSE EU |
2024 |
SAIL.R: A Journey Towards R Software at Johnson & Johnson - A Training Perspective |
Yannick Vandendijck |
source
presentation source |
10 |
| PHUSE EU |
2024 |
The Challenges of Using Parent Study Data in a Long-Term Extension Study |
Kirsty Wall |
source
presentation source |
9 |
| PHUSE EU |
2024 |
The Development of the CDISC eTFL Portal to Support the Adoption and Implementation of the Analysis Results Standard |
Bess LeRoy,
Bhavin Busa |
source
presentation source |
8 |
| PHUSE EU |
2024 |
The Magical Trinity of TLF Automation: Digital Documents, Metadata, and GenAI |
Alastair Scarlett |
source
presentation source |
4 |
| PHUSE EU |
2024 |
The R Journey to Submission |
Hinal Patel,
Welwyn Garden |
source
presentation source |
6 |
| PHUSE EU |
2024 |
The TransCelerate/CDISC Digital Data Flow Project: Practical Electronic Study Designs [presentation] |
David Iberson-Hurst |
source |
8 |
| PHUSE EU |
2024 |
Tips and Tricks: From Specification to Define.xml v2.1 using SAS |
Caroline Pelckmans |
source
presentation source |
18 |
| PHUSE EU |
2024 |
Why Are Old Wines Sometimes Tastier Than New Ones? |
Lars Andersson,
Henning Pontoppidan Föh |
source
presentation source |
10 |
| SESUG |
2024 |
C-SSRS Questionnaire Dataset Design for Assessing Suicide Risk in Neuroscience Studies |
Anupriya Lakshmipathy |
source |
6 |
| SESUG |
2024 |
Streamlining Vaccine Study Output Generation with a Versatile Efficacy Macro |
Zhengyang Shi |
source |
6 |
| WUSS |
2024 |
Automation of Submission of Programs in Analysis Data Reviewer's Guide for FDA and PMDA Submissions |
Junying Zhang |
source |
14 |
| WUSS |
2024 |
Statistical Programmers Role for SPM Analysis |
Marckenley Mercie,
Ce (Colin) Zhou |
source |
11 |
| PharmaSUG CN |
2024 |
An Efficient R Shiny App for Exposure-Response Relationship (E-R) Analysis in Oncology Drug Development |
Zhenghao Chu |
source |
28 |
| PharmaSUG CN |
2024 |
Enhancing Patient Profile Visualization through Clustering Algorithms: An Exploration of Smart Data Presentation Techniques |
Zhengyuan Wen,
Kang Zhao |
source |
8 |
| PharmaSUG CN |
2024 |
Fighting with Special Characters in Data Management Programmer's Daily Work |
Fei Guo |
source |
20 |
| PharmaSUG CN |
2024 |
General Considerations for Integrating ADaM Data and Special Handling of One Complex Case in ISS |
Niandong Yang |
source |
7 |
| PharmaSUG CN |
2024 |
Implementation on concentration-QTc modeling |
Daoqing Li,
Deli Cao |
source |
20 |
| PharmaSUG CN |
2024 |
Implementing Statistical Methods in Companion Diagnostic: A Case Study in NSCLC |
Danxia Hu,
Mandy Gao,
Jianyong Tong |
source |
10 |
| PharmaSUG CN |
2024 |
Metadata-Driven Programming Using R: A Case Study in BDS |
Qian Su,
Renxiang Wang |
source |
13 |
| PharmaSUG CN |
2024 |
MetaTFL - A Dynamic Configuration Application for a Centralized Clinical Analysis Platform |
Cheng Zhang |
source |
8 |
| PharmaSUG CN |
2024 |
Navigating Statistical Programming Challenges in Early Phase Oncology Trials |
Dandan Du |
source |
13 |
| PharmaSUG CN |
2024 |
Programming Perspective: Streamline Estimands, Strategies, and Design ADaM for Estimand |
Yuqin Wu |
source |
10 |
| PharmaSUG |
2024 |
A Programmer-s Insight into an Alternative to TQT Study Data Submission |
Hiba Najeeb,
Raghavender Ranga |
source |
7 |
| PharmaSUG |
2024 |
A Tool for Automated Comparison of Core Variables Across ADaM Specifications Files |
Amy Zhang,
Huei-Ling Chen |
source |
6 |
| PharmaSUG |
2024 |
ADaM Design for Prostate Cancer Efficacy Endpoints Based on PCWG3 |
Lihui Deng,
Kylie Fan,
Jia Li |
source |
10 |
| PharmaSUG |
2024 |
ADaM Discussion Topics: PARQUAL, ADPL, Nadir |
Sandra Minjoe |
source |
7 |
| PharmaSUG |
2024 |
Around the Data DOSE-y Doe, How Much Fun Can Your Data Can Be: Using DOSExx Variables within ADaM Data Sets |
Inka Leprince,
Richann J. Watson |
source |
12 |
| PharmaSUG |
2024 |
Automated Harmonization: Unifying ADaM Generation and Define.xml through ADaM Specifications |
Wei Shao,
Xiaohan Zou |
source |
10 |
| PharmaSUG |
2024 |
Automating the annotation of TLF mocks Using Generative AI |
Vidya Gopal |
source |
6 |
| PharmaSUG |
2024 |
CDISC Therapeutic Area User Guides and ADaM Standards Guidance |
Karin LaPann |
source |
6 |
| PharmaSUG |
2024 |
Define-XML Conversion: A General Approach on Content Extraction Using Python |
Danfeng Fu,
Dickson Wanjau,
Ben Gao |
source |
15 |
| PharmaSUG |
2024 |
Design Considerations for ADaM Protocol Deviations Dataset in Vaccine Studies |
Rashmi Gundaralahalli Ramesh,
Jeffrey Lavenberg |
source |
12 |
| PharmaSUG |
2024 |
Experimenting with Containers and webR for Submissions to FDA in the Pilot 4 |
André Veríssimo,
Ismael Rodriguez |
source |
8 |
| PharmaSUG |
2024 |
Exploit the Window of Opportunity: Exploring the Use of Analysis Windowing Variables |
Richann J. Watson,
Elizabeth Dennis,
Karl Miller |
source |
4 |
| PharmaSUG |
2024 |
Game changer! The new CDISC ADaM domain ADNCA for PK/PD data analysis |
Santosh Ranjan |
source |
7 |
| PharmaSUG |
2024 |
Is a Participation-Level ADaM Dataset a Solution for Submitting Integration Data to FDA? |
Sandra Minjoe |
source |
7 |
| PharmaSUG |
2024 |
Lead-in and extension trials, how we documented datapoint traceability |
Hanne Ellehoj,
Veeresh Namburi |
source |
5 |
| PharmaSUG |
2024 |
Oncology ADaM Datasets Creation Using R Programming: A Comprehensive Approach |
Ishwar Chouhan |
source |
29 |
| PharmaSUG |
2024 |
Ongoing Trends and Strategies to Fine-tune the CRO/Sponsor Partnership - Perspectives from Statistical Programming |
Mathura P. Ramanathan |
source |
10 |
| PharmaSUG |
2024 |
Periodic safety reports of clinical trials |
Murali Kanakenahalli,
Annette Bove,
Smita Sehgal |
source |
8 |
| PharmaSUG |
2024 |
Piloting into the Future: Publicly available R-based Submissions to the FDA |
Benjamin Straub |
source |
9 |
| PharmaSUG |
2024 |
Programming Considerations in Deriving Progression-Free Survival on Next-Line Therapy (PFS2) |
Alec McConnell,
Yun Peng |
source |
5 |
| PharmaSUG |
2024 |
Programming with SAS PROC DS2: Experience with SDTM/ADaM |
Jianfeng Wang,
Li Cheng |
source |
6 |
| PharmaSUG |
2024 |
Protocol Amendments and EDC Updates: Downstream impact on Clinical Trial Data |
Anbu Damodaran,
Ram Gudavalli,
Kumar Bhimavarapu |
source |
11 |
| PharmaSUG |
2024 |
Source Data Quality Issues in PopPK/PD Dataset Programming: a Systematic Approach to Handle Duplicates |
Ibrahim Priyana,
Ellen Winckelmans |
source |
10 |
| PharmaSUG |
2024 |
Submitting Patient-Reported Outcome Data in Cancer Clinical Trials - Guidance for Industry Technical Specifications Document [presentation] |
Flora Mulkey |
source |
48 |
| PharmaSUG |
2024 |
The Role of the Blinded Programmer in Preparation of Data Monitoring Committee Packages (for Clinical Trials) |
Binal Mehta,
Patel Mukesh |
source |
6 |
| PharmaSUG |
2024 |
Transitioning from SAS to R |
Ashley Tarasiewicz,
Chelsea Dickens |
source |
83 |
| PharmaSUG |
2024 |
Translation from statistical to programming: effective communication between programmers and statisticians |
Diana Avetisian |
source |
10 |
| PharmaSUG |
2024 |
Two hats, one noggin: Perspectives on working as a developer and as a user of the admiral R package for creating ADaMs. |
Benjamin Straub |
source |
9 |
| PharmaSUG |
2024 |
Updates on Preparing a BIMO Data Package |
Elizabeth Li,
Carl Chesbrough,
Inka Leprince |
source |
17 |
| PHUSE US |
2024 |
Addressing Challenges in Structuring CDISC SDTM and ADaM Datasets to Report Adverse Events Spanning Two Treatment Periods |
Madhusudhan Reddy Papasani |
source
presentation source |
4 |
| PHUSE US |
2024 |
AI-Enhanced Chatbot for Streamlined Clinical Trial Analysis and Document Management |
Jaime Yan |
source
presentation source |
7 |
| PHUSE US |
2024 |
An End User's Perspective of Clinical Dosing Data Used for Population PK/PD Analysis with Non-Linear Mixed Effects Modelling |
Rebecca Humphrey,
Mitali Gaurav |
source
poster source |
2 |
| PHUSE US |
2024 |
Bridging the Gap Between the pharmaverse and Company Internal Resources |
Kangjie Zhang |
source
presentation source |
8 |
| PHUSE US |
2024 |
Data Handling through CDISC Standards in Master Protocols: A Focus on Rescreened and Re-Enrolled Subjects |
Swathi Kotla,
Madhusudhan Reddy Papasani |
source
presentation source |
7 |
| PHUSE US |
2024 |
Does One Size Fit All? |
Bidhya Basnet |
source
poster source |
4 |
| PHUSE US |
2024 |
Effortless Table Generation: A SAS Macro for Streamlining Your Workflow |
Zhen (Laura) Li |
source
presentation source |
12 |
| PHUSE US |
2024 |
From stowaway to admiral, a R-iveting tale of a hierarchical composite endpoint's journey from idea to dataset |
Nicole Major,
Otto Magnusson |
source
presentation source |
16 |
| PHUSE US |
2024 |
Future Clinical Data Submission Standards: CDISC, FHIR, OMOP, or Hybrid Model |
Jeffrey M. Abolafia,
Sarah Ferko,
Ingeborg Holt |
source
presentation source |
10 |
| PHUSE US |
2024 |
Getting Started with the New CDISC Analysis Results Standard |
Bess LeRoy,
Bhavin Busa,
Richard Marshall |
source
presentation source |
4 |
| PHUSE US |
2024 |
Journey of Reactogenicity Data from EDC to SDTM to Analysis Datasets |
Charumathy Sreeraman |
source
presentation source |
10 |
| PHUSE US |
2024 |
Navigating the Safe Integration of AI (ChatGPT) into Clinical Trials Programming Workflow |
Mykyta Vysotskyi |
source
presentation source |
10 |
| PHUSE US |
2024 |
Optimizing Clinical Research: Using AI for Automated Validation of Output Tables against ADaM |
Steve Ross |
source
presentation source |
5 |
| PHUSE US |
2024 |
Population Pharmacokinetic Analysis Data (ADPPK) Programming in {admiral} and the pharmaverse |
Jeffrey Dickinson |
source
poster source |
9 |
| PHUSE US |
2024 |
Programming Approaches for Integrated Summary of Efficacy (ISE) Development in Oncology |
Narendra Babu Kolisetty,
Saigovind Chenna |
source
presentation source |
7 |
| PHUSE US |
2024 |
R Shiny Application to Optimise Review of Multiple Myeloma Efficacy Data Listings |
Dinesh Putluri |
source
poster source |
2 |
| PHUSE US |
2024 |
SAS ODS Package for Efficient Creation of Zip File for P21 Validation |
Venkatesh Burla |
source
presentation source |
8 |
| PHUSE US |
2024 |
Scaling ECAs from Projects to the Enterprise: Multicentre, Multisource Infrastructure for External Control Arms |
Jussi Leinonen,
Mayur Saxena |
source
presentation source |
4 |
| PHUSE US |
2024 |
Standards Library: Getting started - A Medical Device Case Study |
Amy Booth |
source
presentation source |
6 |
| PHUSE US |
2024 |
TFL Designer: Automating Tables, Figures and Listings Design and Generation for Analysis Results [presentation] |
Navin Dedhia,
Bhavin Busa |
source |
10 |
| PHUSE US |
2024 |
Transformative Strategies in People Leadership and Management for Organisational Success |
Bhanojinaidu Duppada,
Sumanth Goud Bheemagani |
source
presentation source |
8 |
| PHUSE US |
2024 |
Unveiling the Potential of ADNCA via the CDISC ADaM IG: Revolutionising Pharmacokinetic Non-Compartmental Analysis Input Data Standardisation |
Saumilkumar Tripathi |
source
presentation source |
10 |
| PHUSE US |
2024 |
Using R for QC of Tables |
Marcus Trincia |
source
poster source |
3 |
| PHUSE US |
2024 |
USUBJID Challenges: Representing Multiple Participations for Analysis and Reporting |
Emily Bernstein-Hanlon,
Sirisha Davuluri |
source
presentation source |
9 |
| PHUSE EU |
2023 |
Automating ADaM Dataset Generation via Definitive Specification Writing with A Domain-Specific Language |
Kang Zhao |
source
presentation source |
7 |
| PHUSE EU |
2023 |
Challenges in Oncology Modular studies: The Fortrea approach |
Francesca Dall'Acqua |
source
presentation source |
7 |
| PHUSE EU |
2023 |
Experiences of Training Teams in R |
Alanah Jonas |
source
presentation source |
10 |
| PHUSE EU |
2023 |
Experiencing the FDA CBER |
Merve Akram,
Angelo Tinazzi |
source
presentation source |
9 |
| PHUSE EU |
2023 |
Eyes On the Prize - The Development of {admiralophtha}, an R Package for Ophthalmology ADaMs |
Edoardo Mancini |
source
presentation source |
5 |
| PHUSE EU |
2023 |
Further Adventures in SCE Alchemy |
Eleanor Sparling |
source
presentation source |
6 |
| PHUSE EU |
2023 |
H2H Portal - A Shiny Automation of Reproducible and Traceable Analysis and Reporting Using a Metadata Framework |
Julian Schmocker,
Qian Wang |
source
presentation source |
8 |
| PHUSE EU |
2023 |
Handling Multiple Screenings Using the New Domain DC (Demographics for Multiple Participations) at Merck - Implementation of a New Mapping Process [presentation] |
Kristina Zweier |
source |
21 |
| PHUSE EU |
2023 |
Implementation of Estimands Using Data Standards [presentation] |
Chris Price,
Alexandra Cochinaire |
source |
26 |
| PHUSE EU |
2023 |
Interaction with the FDA During and After a Type C Meeting, From the Perspective of a Statistical Programmer |
Dieter Hartz |
source
presentation source |
5 |
| PHUSE EU |
2023 |
Mr. ight - Why R Should Be Used for Validating TLFs in Clinical Trials? |
Monika Ludwinska |
source
presentation source |
10 |
| PHUSE EU |
2023 |
Practical Operations of Electronic Study Data Submissions |
Priyanka Pujari |
source
presentation source |
9 |
| PHUSE EU |
2023 |
Slicing Codes: A Modular approach to ADaM programming |
Mahendran Venkatachalam |
source
presentation source |
10 |
| PHUSE EU |
2023 |
TFL Designer: Automating Tables, Figures and Listings Design and Generation for Clinical Trial Analysis [presentation] |
Bhavin Busa |
source |
10 |
| PHUSE EU |
2023 |
The Curious Case of Observational Studies - A Programmer's Dilemma |
Vikas Shokeen |
source
presentation source |
11 |
| PHUSE EU |
2023 |
Transparent is the New Black - Improving Data Findability Through Better Clinical Metadata |
Lukas Kniola |
source
presentation source |
16 |
| WUSS |
2023 |
Demystifying the define.xml: Overcoming the challenges of CRT Package. |
Yoganand Budumuru |
source |
10 |
| WUSS |
2023 |
Navigating SAS and CDISC Certification with Apprenticeship |
Sarvar Khamidov |
source |
7 |
| SESUG |
2023 |
An Innovative Approach to Generate a CONSORT Diagram in Clinical Trials |
Lydia Li,
Shunbing Zhao |
source |
6 |
| PharmaSUG |
2023 |
A case study of a successful RTOR submission and approval for Rylaze |
Sudhir Kedare,
Dilip Nalla,
Kumud Kanneganti,
Jagan Mohan Achi |
source |
6 |
| PharmaSUG |
2023 |
A Light-Weight Framework to Manage Programs and Run All the TLFs in R |
Chi-Hua Huang |
source |
27 |
| PharmaSUG |
2023 |
A utility to combine study outputs into all-in-one PDF for DSUR |
Wei Shao |
source |
8 |
| PharmaSUG |
2023 |
ADaM Datasets with Multiple Participations per Subject |
Grace Fawcett,
Sandra Minjoe,
Elizabeth Dennis |
source |
7 |
| PharmaSUG |
2023 |
Admiralonco - The Cross-Company R Package for Oncology Admirers |
Neharika Sharma,
Matthew Marino |
source |
25 |
| PharmaSUG |
2023 |
Automation of Dataset Programming Based on Dataset Specification |
Liqiang He |
source |
7 |
| PharmaSUG |
2023 |
Automation of the SDSP CBER Appendix for Vaccine Studies |
Nicole Jones,
Pritesh Solanki |
source |
6 |
| PharmaSUG |
2023 |
Confirmation of Best Overall Tumor Response in Oncology Clinical Trials per RECIST 1.1 |
Danyang Bing |
source |
3 |
| PharmaSUG |
2023 |
Hard Coding: What is it? Why Does It Matter? What Should You Do When Faced With Such A Request? |
Michael Nessly |
source |
4 |
| PharmaSUG |
2023 |
How Can I Put This? - Using a pre-defined spreadsheet to explain your Pinnacle 21 Enterprise Issues |
Mike Lozano |
source |
12 |
| PharmaSUG |
2023 |
Integrating Practices: How Statistical Programmers Differ and Align Within User Groups |
Valeria Duran,
Radhika Etikala,
Haimavati Rammohan |
source |
15 |
| PharmaSUG |
2023 |
Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies |
Xiangchen (Bob) Cui |
source |
29 |
| PharmaSUG |
2023 |
OCS Update: OCS Clinical Services & the Traceability Assessment |
Jesse Anderson |
source |
25 |
| PharmaSUG |
2023 |
Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE |
Elizabeth Dennis,
Monika Kawohl,
Paul K. Slagle |
source |
7 |
| PharmaSUG |
2023 |
Questionnaires in ADaM: ADSF36 |
Keith Shusterman,
Megan O'Grady,
Mario Widel |
source |
13 |
| PharmaSUG |
2023 |
Sound SDTM, Sound ADaM - Orchestrating SDTM and ADaM Harmonization |
Nancy Brucken,
David Neubauer,
Soumya Rajesh |
source |
8 |
| PharmaSUG |
2023 |
Standardized data handling framework for wearables |
Madhu Annamalai,
Umayal Annamalai |
source |
4 |
| PharmaSUG |
2023 |
Study Data Technical Rejection Criteria (TRC) Considerations for Multiple Data Packages in a Single Submission |
Christine S Teng,
Janet Low,
Si Ru Tang |
source |
10 |
| PharmaSUG |
2023 |
The Phantom of the ADaM: adding missing records to BDS datasets |
Anastasiia Drach |
source |
10 |
| PharmaSUG |
2023 |
Traceability: Not just about Data |
Rohit Nagpal,
Kavitha Mullela |
source |
11 |
| PharmaSUG |
2023 |
We Can Work it Out: Dos and Don-ts for Small Biotech and CRO NDA/BLA submission partnership |
Charity Quick,
Jiaan Illidge |
source |
8 |
| PHUSE US |
2023 |
Admiralonco - The Cross-Company R Package for Oncology Admirers [presentation] |
Neharika Sharma,
Matt Marino |
source
video |
11 |
| PHUSE US |
2023 |
An Open-Sourced R Package for Streamlining Generation of Standard TLFs in Both Static and Interactive Formats [presentation] |
Lena Wang,
Heng Wang |
source
video |
25 |
| PHUSE US |
2023 |
Automating SDTM and ADaM Creation in Clinical Trials |
Lyubov Sushchenko,
Rie Ichihashi |
source
presentation source |
9 |
| PHUSE US |
2023 |
Automation of ADaM Dataset & TFL Visualization Through an R Package - GenAdam2 |
Mahesh Divakaran |
source
presentation source |
5 |
| PHUSE US |
2023 |
Big Pharma Acquires Biotech - Perceptions from The Clinical Data Scientists' Point of View |
Jonas Poulsson,
Henning Pontoppidan Föh |
source
presentation source |
10 |
| PHUSE US |
2023 |
Computerised Algorithm for Multiple Myeloma Response Assessments |
Mahesh Swaminathan |
source
presentation source |
3 |
| PHUSE US |
2023 |
Connecting Tables, Listings and Figures [presentation] |
Stella Guo |
source
video |
11 |
| PHUSE US |
2023 |
Efficient Integration Programming Techniques [poster] |
Vaibhav Sathe,
Aparna Polisetty |
source |
1 |
| PHUSE US |
2023 |
FDA Dataset Walkthrough - Statistical Programming Perspectives |
Ketan Durve,
Rachit Desai |
source
presentation source |
7 |
| PHUSE US |
2023 |
FORESTLY - An R Package to Generate Interactive Forest Plots |
Bingjun Wang,
Yilong Zhang |
source
presentation source |
14 |
| PHUSE US |
2023 |
Implementation of Estimands (ICH E9 (R1)) Using Data Standards [presentation] |
Banoo Madhanagopal,
Lori Van Meter |
source
video |
32 |
| PHUSE US |
2023 |
Incremental Automation - Lessons from a Pragmatic and Agile Journey of Improvement [presentation] |
Todd Bazin,
Anuja Das |
source
video |
31 |
| PHUSE US |
2023 |
Managing Deliverables in Oncology Basket Trials |
Hong Qi,
Mary N. Varughese |
source
presentation source |
6 |
| PHUSE US |
2023 |
SAS Macro for Converting Variable Attributes from XLSX Specifications to SDTM/ADAM SAS data sets |
Jinquan Wu |
source
presentation source |
8 |
| PHUSE US |
2023 |
Say No to Stale Data!! Implementation of Automated GxP Data Pipelines Using KNIME [presentation] |
Shiva Katepalli,
Jeffrey Xiong |
source
video |
30 |
| PHUSE US |
2023 |
Scrutinize Tables Listings Figures (TLFs) Prior to Customer Delivery |
Vijetha Kode |
source
presentation source |
6 |
| PHUSE US |
2023 |
Shiny for Submissions [presentation] |
Philip Bowsher,
Eric Nantz |
source |
22 |
| PHUSE US |
2023 |
The Ultimate Update to ADaM Specification Template that Simplifies ADaM Programming and Creation of Define XML [presentation] |
Yuanyuan Liu,
Xiang Wang |
source
video |
18 |
| PHUSE US |
2023 |
Tidytlg: An R Package for Clinical Reporting Using Tidyverse |
Sheng-Wei Wang |
source
presentation source |
9 |
| PHUSE US |
2023 |
Up-to-Date with Dates - Imputation Rules in R Compared to SAS |
Monika Ludwinska |
source
presentation source |
10 |
| PHUSE EU |
2022 |
An Approach to Effectively Reproduce TFLs When Performing ADaM Conversion [presentation] |
Amine Khemiri,
Caroline Pelckmans |
source
video |
19 |
| PHUSE EU |
2022 |
Automation of Standard ADaM Variables Through an R Package - GenAdam |
Mahesh Divakaran |
source
presentation source |
8 |
| PHUSE EU |
2022 |
Breaking Down the Data Standards Silos - A New Metadata Ontology for Data Analysis Derivations |
Chris Price,
Nelia Lasierra |
source
presentation source |
7 |
| PHUSE EU |
2022 |
CDISC Analysis Results Standard - Update and Progress |
Karl Wallendszus,
Hansjörg Frenzel |
source
presentation source |
7 |
| PHUSE EU |
2022 |
Decoding in R |
Himani Narang |
source
presentation source |
5 |
| PHUSE EU |
2022 |
Functional Programming: What, Why and How? |
Tom Ratford |
source
presentation source |
8 |
| PHUSE EU |
2022 |
GSK Diversity Paper: The Challenges We Faced with Real-world Data |
Harrison James,
Chris Leach |
source
presentation source |
43 |
| PHUSE EU |
2022 |
Leveraging Information from Healthy Volunteers' Placebo Data [presentation] |
Koen Ven |
source
video |
17 |
| PHUSE EU |
2022 |
Overcoming Challenges of Your Integrated Summary ISS/ISE Submissions |
Jenet Cp,
Akhil Vijayan |
source
presentation source |
7 |
| PHUSE EU |
2022 |
R Shiny Apps: To QC or Not to QC? [presentation] |
Katie Withycombe |
source
video |
19 |
| PHUSE EU |
2022 |
Streamlining the Usage of SAS, R and Python in our Process Workflow [presentation] |
Sayem Rahman,
Shafi Chowdhury |
source |
8 |
| PHUSE EU |
2022 |
Table of Contents (TOC) - An Application of PowerShell |
Sumit Pratap Pradhan,
Navneet Agnihotri |
source
video
presentation source |
6 |
| PHUSE EU |
2022 |
The Integration Dilemma |
Angelo Tinazzi |
source
video
presentation source |
15 |
| PHUSE EU |
2022 |
The Secret to Getting Your Dream Job Offer [presentation] |
Tom Oades |
source
video |
13 |
| PHUSE EU |
2022 |
Trimmed Mean Analysis Is Not Rocket Science [presentation] |
Kateryna Fedoryshyna |
source
video |
18 |
| SESUG |
2022 |
One Click Excel Cleanup - Generate High Quality SDTM/ADAM Specification |
Suresh Acharya |
source |
8 |
| WUSS |
2022 |
Quick Jumpstart into Pharmaceutical SAS Programming |
Jim Box,
Matthew J. Becker |
source |
7 |
| WUSS |
2022 |
TrackCHG: A SAS Macro to Colorize and Track Changes Between Data Transfers in Subject-Level Safety Listings |
Inka Leprince,
Elizabeth Li,
Carl Chesbrough |
source |
21 |
| PharmaSUG |
2022 |
A Dynamic Data Visualization Report for Efficacy Endpoints of Early Oncology Study |
Hong (Lily) Zhang,
Yixin Ren,
Huei-Ling Chen |
source |
10 |
| PharmaSUG |
2022 |
A SAS Macro to Support the Supplemental Qualifier Section in cSDRG |
Jamuna Purma,
Bindya Bindya Vaswani |
source |
9 |
| PharmaSUG |
2022 |
A Shiny App to Spell Check an ADaM Specification |
Simiao Ye,
Jeff Xia |
source |
9 |
| PharmaSUG |
2022 |
Above and Beyond Lesion Analysis Dataset (ADTL) |
Raghava Pamulapati |
source |
11 |
| PharmaSUG |
2022 |
ADCM Macro Design and Implementation |
Chengxin Li,
Tingting Tian,
Toshio Kimura |
source |
7 |
| PharmaSUG |
2022 |
Automation of Clinical Data extracts using Cloud Applications |
Syam Prasad Chandrala,
Madhusudhan Nagaram,
Chaitanya Chowdagam,
Jegan Pillaiyar,
Kunal Chattopadhyay |
source |
9 |
| PharmaSUG |
2022 |
Clinical Classifications: Getting to know the new kid on the QRS block! |
Soumya Rajesh,
Michael Wise |
source |
9 |
| PharmaSUG |
2022 |
Derivation of Efficacy Endpoints by iRECIST Criteria: A Practical Approach |
Ilya Krivelevich,
Lei Gao,
Richard Kennan |
source |
9 |
| PharmaSUG |
2022 |
Following Your Footsteps: Maintaining Traceability in ADaM Datasets |
Nancy Brucken,
Karl Miller |
source |
58 |
| PharmaSUG |
2022 |
Generating statistical Tables, Listings, and figures using machine learning, deep learning, and NLP techniques that provide more efficiency to the statistical programming process |
Farha Feroze,
Ilango Ramanujam |
source |
3 |
| PharmaSUG |
2022 |
Including Population Information in ADaM define.xml for Better Understanding of Datasets |
Hong Qi,
Majdoub Haloui,
Guowei Wu |
source |
6 |
| PharmaSUG |
2022 |
Lessons Learned from Using P21 to Create ADaM define.xml with Examples |
Yizhuo Zhong,
Christine S Teng,
Majdoub Haloui |
source |
8 |
| PharmaSUG |
2022 |
Making an ADaM Dataset Analysis-Ready |
Sandra Minjoe |
source |
10 |
| PharmaSUG |
2022 |
PROC FUTURE PROOF 1.2 - Linked Data |
Danfeng Fu,
Ellie Norris,
Suhas R. Sanjee,
Susan Kramlik |
source |
13 |
| PharmaSUG |
2022 |
Quality Control With External Code |
Bill Coar |
source |
7 |
| PharmaSUG |
2022 |
Quality Gates: An Overview from Clinical SAS Programming Perspective |
Nagadip Rao,
Pavan Jupelli |
source |
10 |
| PharmaSUG |
2022 |
Real Time Oncology Review Readiness from Programming Perspective |
Binal Mehta,
Patel Mukesh |
source |
10 |
| PharmaSUG |
2022 |
SAS Macro to Colorize and Track Changes Between Data Transfers in Subject-Level Listings |
Inka Leprince,
Elizabeth Li,
Carl Chesbrough |
source |
19 |
| PharmaSUG |
2022 |
SAS ODS Application of Interactive and Informative Clinical Trial Reports |
Luwei Pang,
Aiming Yang |
source |
9 |
| PharmaSUG |
2022 |
Subjects Enrolled in Multiple Cohorts within a Study - Challenges and Ideas |
Peng Du,
Hongli Wang |
source |
7 |
| PharmaSUG |
2022 |
Upgrading from Define-XML 2.0 to 2.1 |
Trevor Mankus |
source |
6 |
| PHUSE US |
2022 |
Automating Analysis Result Metadata [presentation] |
Ghanshyam Jangid |
source
video |
17 |
| PHUSE US |
2022 |
CDISC Analysis Results Standards - Approach and Development Update [presentation] |
Bess LeRoy,
Jeffrey M. Abolafia,
Bhavin Busa |
source |
18 |
| PHUSE US |
2022 |
Clinical Data Standardization and Integration Using Data Warehouse and Data Mart Processes [presentation] |
Clio Wu |
source |
15 |
| PHUSE US |
2022 |
Collection, Standardization, and Reporting of Adverse Events with Toxicity Changes Using CDISC Standards in Oncology Clinical Trials |
Madhusudhan Reddy Papasani,
Swathi Kotla,
Elisabeth Pyle |
source
video
presentation source |
12 |
| PHUSE US |
2022 |
Navigation of Professional Development Planning Through the Performance Appraisal Process [presentation] |
Parag Shiralkar |
source
video |
13 |
| PHUSE US |
2022 |
Pan-pharma Industry Collaboration - New Horizon, Success Stories [presentation] |
Tadeusz Lewandowski |
source
video |
21 |
| PHUSE US |
2022 |
Using the Nest-map-unnest Workflow in R for Sub-group Analysis in Clinical Trial Reporting [presentation] |
Mia Qi,
Sheng-Wei Wang |
source
video |
12 |
| PHUSE US |
2022 |
Vaccine Trials: The Basics You Need to Know [presentation] |
Prashanthi Selvakumar |
source |
11 |
| PHUSE EU |
2021 |
A Beginner's Guide to Data Analysis |
Shuva Dey |
source
video |
15 |
| PHUSE EU |
2021 |
Advanced Excel Specification for Automatic SDTM Generation |
Aleksandra Gorbunova,
Ilya Mishchenko |
source
video
presentation source |
10 |
| PHUSE EU |
2021 |
Clinical Design - Visualisation and Analysis Using the Interactive Application by R Shiny |
Athira Sudhakar,
Mahesh Divakaran |
source
video |
7 |
| PHUSE EU |
2021 |
Code Sharing is Caring [presentation] |
Lucy Palmen |
source
video |
16 |
| PHUSE EU |
2021 |
F3: Fitness, FAIR & Filing [presentation] |
Bhupendra Mistry,
Nigel Montgomery |
source
video |
19 |
| PHUSE EU |
2021 |
How to Be Traceable in ADaM |
Angelo Tinazzi |
source
video
presentation source |
9 |
| PHUSE EU |
2021 |
Integrated Summary of Safety and Efficacy Production Strategies |
Navneet Agnihotri,
Sumit Pratap Pradhan |
source
video
presentation source |
9 |
| PHUSE EU |
2021 |
Metadata: Errors Not Detected by the Pinnacle 21 Tool [presentation] |
Caroline Pelckmans,
Pamphile Beaujean |
source
video |
20 |
| PHUSE EU |
2021 |
Methods and Challenges of R Validation for Regulatory Submission Analysis [presentation] |
Parvee Kumar |
source
video |
14 |
| PHUSE EU |
2021 |
Multi-study programming - a best practice outline |
Simon Purkess,
Matt Metherell |
source
video
presentation source |
9 |
| PHUSE EU |
2021 |
New Starters Session: The Secret Sauce to Start in Our Industry [presentation] |
Amritpal Singh,
Lucie Bowden |
source |
7 |
| PHUSE EU |
2021 |
New Starters Session: The Secret Sauce to Start in Our Industry [presentation] |
Amritpal Singh,
Lucie Bowden |
source |
11 |
| PHUSE EU |
2021 |
Preparing PK/PD ADaM Datasets and eCRT Data Package for FDA Submission |
Junying Zhang |
source
video
presentation source |
11 |
| PHUSE EU |
2021 |
Real-world Data, CDISC SDTM, HL7 FHIR and the Future of Regulatory Submissions [presentation] |
Jozef Aerts |
source
video |
17 |
| PHUSE EU |
2021 |
The Value of Optimising Your CDISC Analysis Data Model (ADaM) Specifications [presentation] |
Amine Khemiri,
Caroline Pelckmans |
source
video |
17 |
| PHUSE US |
2021 |
A Well Design QC Toolkit for Clinical Programming Compliance Checking [presentation] |
Huei-Ling Chen,
Sandeep Meesala |
source
video |
30 |
| PHUSE US |
2021 |
ADaM Generator Tool [presentation] |
Gustav Bernard |
source
video |
45 |
| PHUSE US |
2021 |
Automation of a Web-based Metadata Repository for SAS Datasets with Selenium Technology [presentation] |
Eugene Tsykalov |
source
video |
14 |
| PHUSE US |
2021 |
China Center for Drug Evaluation, NMPA Electronic Study Data Submission Requirements [presentation] |
Majdoub Haloui,
Yanhong Li |
source
video |
16 |
| PHUSE US |
2021 |
COVID-19 Presentation: CO01: Harnessing the Power of Shiny to Visualize Missing Data due to the COVID-19 Pandemic [presentation] |
Mark Rothe,
Sangeeta Bhattacharya |
source |
13 |
| PHUSE US |
2021 |
Digitalization, Agile Mindset and Virtual Collaboration - Yet Delivering a "Pile of Paper"? [presentation] |
Jesper Zeth,
Parag Wani |
source
video |
17 |
| PHUSE US |
2021 |
Good Cooperation Between SAS and R for Regulatory Submission [presentation] |
Jingyuan Chen |
source
video |
19 |
| PHUSE US |
2021 |
Managing TFL Development in LSAF 5.3 Using SAS and R Code [presentation] |
Jean-Marc Ferran,
Stijn Rogiers |
source
video |
33 |
| PHUSE US |
2021 |
Planning and Execution of Real-world Data Evidence Analysis |
Nicole Thorne,
Ramesh Sundaram |
source
video
presentation source |
6 |
| PHUSE US |
2021 |
Processes and Techniques for Creating Integrated Summary of Safety (ISS) |
Ghanshyam Jangid,
Jane E. Marrer |
source
video
presentation source |
9 |
| PHUSE US |
2021 |
Python for Visualization in Solid Tumor Studies |
Hengwei Liu |
source
video
presentation source |
10 |
| PHUSE US |
2021 |
Software Demonstration: SD12: Reporting Application that Provides Instant Oversight to Management and Actively Helps Programmers to Save Time, Implement Standards and Raise Quality [presentation] |
Shafi Chowdhury |
source |
11 |
| PHUSE US |
2021 |
Standing Room Only Presentation: DS06: CDISC Analysis Results Standard [presentation] |
Bess LeRoy |
source |
25 |
| PHUSE US |
2021 |
Template of Analysis Reviewer's Guide in Oncology [presentation] |
Hong Qi,
Mary N. Varughese |
source
video |
19 |
| PharmaSUG |
2021 |
A Lead Programmer-s Guide to a Successful Submission |
Pranav Soanker,
Santosh Shivakavi |
source |
8 |
| PharmaSUG |
2021 |
A SAS Macro to Generate Slim Version of Define for RTOR |
Jeff Xia |
source |
8 |
| PharmaSUG |
2021 |
ADaM Implementation Guide for Medical Devices |
Julia Yang,
Silvia Faini,
Karin LaPann |
source |
11 |
| PharmaSUG |
2021 |
ADaM-like Dataset: how to do big things in a short time |
Oksana Mykhailova,
Andrii Klekov |
source |
7 |
| PharmaSUG |
2021 |
Archival Tool: Automation using PowerShell |
Sumit Pratap Pradhan |
source |
9 |
| PharmaSUG |
2021 |
Challenges and Solutions for an ISM Development |
Si Ru Tang,
Yanhong Li |
source |
9 |
| PharmaSUG |
2021 |
Design ADaM Specification Template that Simplifies ADaM Programming and Creation of Define XML in CDISC Era |
Xiang Wang,
Daniel Huang |
source |
11 |
| PharmaSUG |
2021 |
e-Submissions key difference of FDA and PMDA |
Giri Prasad,
Hareeshkumar Gurrala |
source |
8 |
| PharmaSUG |
2021 |
Effective Approach for ADaM Submission to FDA and PMDA |
Ranvir Singh |
source |
6 |
| PharmaSUG |
2021 |
Macro Development from Design to Implementation Applied to Occurrence Data Frequency Analysis |
Chengxin Li,
Michael Pannucci,
Toshio Kimura |
source |
9 |
| PharmaSUG |
2021 |
Neoadjuvant and Adjuvant Oncology Clinical Trials and Considerations for Designing the Subject Level Analysis Dataset (ADSL) |
Madhusudhan Reddy Papasani,
Swathi Kotla,
Elisabeth Pyle |
source |
9 |
| PharmaSUG |
2021 |
New Requirements of Clinical Trial Data Submission for China Filing: An Implementation |
Yuan Yuan Dong,
Wang Zhang,
Lily Ling |
source |
5 |
| PharmaSUG |
2021 |
Only Get What You Need - To Simplify Analysis Data Validation Report from PROC COMPARE Output |
Wenjun He |
source |
12 |
| PharmaSUG |
2021 |
PROC FUTURE PROOF v1.1 - Linked Data |
Amy Gillespie,
Susan Kramlik,
Suhas R. Sanjee,
Jindřich Mynarz,
Danfeng Fu |
source |
12 |
| PharmaSUG |
2021 |
Shiny App for Generating Data Dependency Flowchart in ADRG |
Simiao Ye,
Yilong Zhang |
source |
8 |
| PharmaSUG |
2021 |
When Should I Break ADaM Rules? |
Sandra Minjoe |
source |
8 |
| SGF |
2021 |
Analyzing Data Missing Due to COVID-19: From Raw Data to ADaM and Beyond |
Yuliia Bahatska |
source
presentation |
12 |
| PHUSE EU |
2020 |
A Collaborative Approach to Analysis Standards [presentation] |
Margie Merlino,
Marleen Nijs |
source
video |
22 |
| PHUSE EU |
2020 |
ADaM Datasets - Why Do We Produce Them? [presentation] |
Kate Booth |
source
video |
27 |
| PHUSE EU |
2020 |
ADaM is Back: The New ADaM IG 1.2 and Beyond |
Angelo Tinazzi |
source
video |
8 |
| PHUSE EU |
2020 |
Advancing SDTM Annotation Through Automation [presentation] |
Anja Kreis,
Wolfgang Rohnert |
source
video |
20 |
| PHUSE EU |
2020 |
Are We on the Same Page - Trial-level Metadata Based Upon Project Metadata [presentation] |
Bo Sølgaard Andersen,
Frederik Vandvig Heinen |
source
video |
18 |
| PHUSE EU |
2020 |
Define-XML for ADaM: Clinical Standards Toolkit vs. Pinnacle 21? [presentation] |
Frederikke Høyer |
source
video |
16 |
| PHUSE EU |
2020 |
Effective Data Integrations [poster] |
Kirsty Wall,
Nicola Perry |
source
video |
1 |
| PHUSE EU |
2020 |
Flow Dependencies in ADaM Generation |
Ari Siggaard Knoph,
Jeppe Juul |
source
video
presentation source |
6 |
| PHUSE EU |
2020 |
Guide to Electronic Submission of Pharmacometric Datasets and Analyses to the Regulatory Authorities [presentation] |
Pooja Kulkarni |
source
video |
17 |
| PHUSE EU |
2020 |
Improve Programming and Traceability with Datasets for Statistical Analysis Results |
Henning Pontoppidan Föh,
Jeppe Juul |
source
video
presentation source |
4 |
| PHUSE EU |
2020 |
Metadata to Support ADaM Generation [presentation] |
Anne Katrine Alsing,
Jeppe Juul |
source
video |
14 |
| PHUSE EU |
2020 |
Please Take Care of Your Metadata |
Angelo Tinazzi |
source
video
poster source |
5 |
| PHUSE EU |
2020 |
Pooling lab data to support FDA submission: keep it clear and simple |
Joske van Schijndel |
source
video |
5 |
| PHUSE EU |
2020 |
Rise and Shine: Using R Shiny to explore insomnia clinical trial data |
Matthew Brierley |
source
video
presentation source |
6 |
| PHUSE EU |
2020 |
Using R from End to End: CDISC SDTM and ADaM into .xpt and Output Generation [presentation] |
Antonio Rodríguez Contestí |
source
video |
46 |
| PHUSE EU |
2020 |
Utilising Automation for Mass Model Creation to Improve the Economics of Machine Learning Projects [presentation] |
Alex Tsui |
source
video |
18 |
| PharmaSUG |
2020 |
An Effective Management Approach for a First-Time Study Lead |
Himanshu Patel,
Jeff Xia |
source |
10 |
| PharmaSUG |
2020 |
Analysis Package e-Submission - Planning and Execution |
Abhilash Chimbirithy,
Saigovind Chenna,
Majdoub Haloui |
source |
8 |
| PharmaSUG |
2020 |
Automate your Safety tables using Artificial Intelligence & Machine Learning |
Roshan Stanly,
Ajith Baby Sadasivan,
Limna Salim |
source |
8 |
| PharmaSUG |
2020 |
Automating of Two Key Components in Analysis Data Reviewer's Guide |
Shunbing Zhao,
Jeff Xia |
source |
8 |
| PharmaSUG |
2020 |
Butterfly Plot for Comparing Two Treatment Responses |
Raghava Pamulapati |
source |
13 |
| PharmaSUG |
2020 |
Data Review: What's Not Included in Pinnacle 21? |
Jinit Mistry,
Lyma Faroz,
Hao Meng |
source |
7 |
| PharmaSUG |
2020 |
Generating ADaM compliant ADSL Dataset by Using R |
Vipin Kumpawat,
Lalitkumar Bansal |
source |
9 |
| PharmaSUG |
2020 |
Improving the Quality of Define.xml: A Comprehensive Checklist Before Submission |
Ji Qi,
Yan Li,
Lixin Gao |
source |
8 |
| PharmaSUG |
2020 |
MKADRGM: A Macro to Transform Drug-Level SDTM Data into Traceable, Regimen-Level ADaM Data Sets |
Sara McCallum |
source |
34 |
| PharmaSUG |
2020 |
Natural History Study - A Gateway to Treat Rare Disease |
Tabassum Ambia |
source |
5 |
| PharmaSUG |
2020 |
Preparing a Successful BIMO Data Package |
Elizabeth Li,
Carl Chesbrough,
Inka Leprince |
source |
20 |
| PharmaSUG |
2020 |
PROC Future Proof; |
Amy Gillespie,
Susan Kramlik,
Suhas R. Sanjee |
source |
8 |
| PharmaSUG |
2020 |
Project Metrics - a powerful tool that supports workload management and resource planning for Biostats & Programming department. |
Jian Hua (Daniel) Huang,
Rajan Vohra,
Andy Chopra |
source |
11 |
| PharmaSUG |
2020 |
SDSP: Sponsor and FDA Liaison |
Bhanu Bayatapalli,
Shefalica Chand |
source |
8 |
| PharmaSUG |
2020 |
SDTM to ADaM Programming: Take the Leap! |
Jennifer McGrogan,
Alyssa M. Wittle |
source |
5 |
| PharmaSUG |
2020 |
Standard Analyses and Code Sharing Working Group Update |
Nancy Brucken,
Dante Di Tommaso,
Jane E. Marrer,
Mary Nilsson,
Jared Slain,
Hanming Tu |
source |
5 |
| PharmaSUG |
2020 |
Standardised MedDRA Queries (SMQs): Programmers Approach from Statistical Analysis Plan (SAP) to Analysis Dataset and Reporting |
Sumit Pratap Pradhan |
source |
18 |
| PharmaSUG |
2020 |
Supplementary Steps to Create a More Precise ADaM define.xml in Pinnacle 21 Enterprise |
Majdoub Haloui,
Hong Qi |
source |
10 |
| PHUSE US |
2020 |
A Collaborative Approach to Analysis Standards |
Margaret Merlino,
Marleen Nijs |
source
poster source |
5 |
| PHUSE US |
2020 |
A Comparison of Machine Learning Algorithms for Binary Classification of Free-text Fields Using SAS, R, and Python |
Michael S Rimler |
source
presentation source |
12 |
| PHUSE US |
2020 |
Automating the Analysis Data Reviewer's Guide (ADRG) in Early-stage Development Studies |
Jing Su,
Pranab K. Mitra |
source |
5 |
| PHUSE US |
2020 |
Be the Master for a Master Protocol Study |
Ke Xiao |
source
poster source |
8 |
| PHUSE US |
2020 |
Building a Deeper Bench: Writing ADaM Specifications |
Kristen Reece Harrington,
Shane Rosanbalm |
source
presentation source |
3 |
| PHUSE US |
2020 |
Case Study: Integrated SDTM to Integrated ADaM to TLFs |
Kishore Pothuri |
source
presentation source |
6 |
| PHUSE US |
2020 |
Data Standards Used for Electronic Submission of Real-World Evidence in New Drug Application (NDA) |
Nicole Thorne,
Kathy Wu |
source
presentation source |
10 |
| PHUSE US |
2020 |
Documentation, Applicability and Automation: How Best Practices Can Help You Achieve Best Results |
Aadesh Shah |
source
presentation source |
7 |
| PHUSE US |
2020 |
Efficacy ADaMs in Oncology - Step by Step (Dataset by Dataset) |
Ilya Krivelevich,
Ran Xie |
source
presentation source |
8 |
| PHUSE US |
2020 |
End-to-End Interactive TLF Using R Shiny |
Rohit Banga |
source
presentation source |
13 |
| PHUSE US |
2020 |
Handling Missing Data in Clinical Trials: Techniques and Methods |
Pennidhi Karlakunta,
Naveen Kommuru |
source
presentation source |
9 |
| PHUSE US |
2020 |
How to Handle the Challenges for the Content of Specific Datasets in FDA Submission for HIV Drugs |
Fangfang Du |
source
presentation source |
6 |
| PHUSE US |
2020 |
How to reduce programming time for ADaM Creation? - Presenting STAG, a Tool Based Approach |
Diganta Bose |
source
presentation source |
16 |
| PHUSE US |
2020 |
Industry Experiences Submitting Standardized Study Data to Regulatory Authorities |
Janet Low,
Vincent Guo |
source
presentation source |
12 |
| PHUSE US |
2020 |
Let Us Trace Back to the Beginning from the End |
Madhusudhan Reddy Papasani,
Swathi Kotla |
source
presentation source |
12 |
| PHUSE US |
2020 |
Managing Simultaneous Drug Submissions with Breakthrough Designations - Lessons Learned from a Programming Perspective |
LiFeng Good |
source
presentation source |
6 |
| PHUSE US |
2020 |
R Shiny Applications Within Ophthalmology |
Julia Dedic |
source
presentation source |
8 |
| PHUSE US |
2020 |
Real-time Oncology Review - Applicant Experience |
Annie Varghese |
source
presentation source |
5 |
| PHUSE US |
2020 |
Regulatory Report Automation with R |
Shimeng Huang,
Suwen Li |
source
presentation source |
5 |
| PHUSE US |
2020 |
The JumpStart Traceability Assessment |
Tejas Patel,
Sarah Ferkov |
source |
10 |
| PHUSE US |
2020 |
The Misery of the Miscellaneous Folder in Module 5 |
Marguerite Kolb |
source
presentation source |
8 |
| PHUSE US |
2020 |
Using Standardization and Automation to Streamline Generation of SDTM/ADaM Codelists |
Eric Du |
source |
6 |
| PHUSE EU |
2019 |
ADaM Submission - How to Work with the Inconsistencies Between the FDA and PMDA Requirements |
Marianne Carames |
source
presentation source |
5 |
| PHUSE EU |
2019 |
ADaM-based Centralised Monitoring |
Christian S. Christensen |
source
presentation source |
3 |
| PHUSE EU |
2019 |
ADSL - Friend or Foe? |
Jørgen Mangor Iversen |
source
presentation source |
8 |
| PHUSE EU |
2019 |
Basics of Dataset Integration |
Pradeep Kumar |
source
presentation source |
4 |
| PHUSE EU |
2019 |
CDISC 360: Continuing the Journey Towards End-to-End Automation |
Peter Van Reusel |
source
presentation source |
3 |
| PHUSE EU |
2019 |
Challenges Involved with Using Legacy Clinical Trial Study Data During Integration |
Adebola Opasanya |
source
poster source |
8 |
| PHUSE EU |
2019 |
Development of standard BIMO process to create clinsite dataset |
Hilde Delanghe |
source
presentation source |
8 |
| PHUSE EU |
2019 |
Don't cha wish your tracker was clean like mine? |
Anisa Jeetoo |
source
presentation source |
8 |
| PHUSE EU |
2019 |
How Can We Ensure Our Study Data is F.A.I.R. (Findable, Accessible, Interoperable and Reusable)? |
Alana Harris |
source
presentation source |
4 |
| PHUSE EU |
2019 |
Lessons Learned from an FDA Real-time Oncology Review Pilot Programme: A Novartis & Roche Perspective |
Delphine Kerzerho,
Hiren Naygandhi |
source
presentation source |
10 |
| PHUSE EU |
2019 |
Line Management and Mentoring |
Tom Ward |
source
presentation source |
6 |
| PHUSE EU |
2019 |
Onboarding a Junior Statistical Programmer in 10 Weeks: My Story, from University to First Analysis Delivery |
Pieter Coppens,
Annelies Van Zeveren |
source
presentation source |
6 |
| PHUSE EU |
2019 |
Optimise PRO Data Analysis with an Interactive Approach |
Tadeusz Lewandowski |
source
presentation source |
9 |
| PHUSE EU |
2019 |
PHUSE CDISC Implementation Primer Project Overview and Update |
Beate Hientzsch,
Nick De Donder |
source
poster source |
4 |
| PHUSE EU |
2019 |
Programming in the World of PK: Guidance for the Beginner |
Paige Lewis |
source
poster source |
7 |
| PHUSE EU |
2019 |
Quality Control and Validation - More Than Just PROC COMPARE |
Evgeny Starostin |
source
poster source |
7 |
| PHUSE EU |
2019 |
Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis |
Jeffrey M. Abolafia,
Priya Gopal,
Samuel Hume |
source
presentation source |
12 |
| SESUG |
2019 |
ePRO: A View from Statistical Programmer |
Vijetha Kode,
Saigovind Chenna |
source |
18 |
| SESUG |
2019 |
One Click to Analysis Results Metadata |
Srivathsa Ravikiran,
Priscilla Gathoni |
source |
18 |
| MWSUG |
2019 |
Timing is Everything: Defining ADaM Period, Subperiod and Phase |
Nancy Brucken |
|
7 |
| WUSS |
2019 |
Automating ADSL Programming Using Pinnacle 21 Specifications |
Tracy Sherman,
Aakar Shah |
source |
12 |
| PharmaSUG |
2019 |
A Practical Guide to the Issues Summary in the Data Conformance Summary of Reviewer's Guides |
Gary E. Moore |
source |
15 |
| PharmaSUG |
2019 |
ADaM 1.1 Compliant ADEVENT and ADTTE development in a Cardiovascular Study |
Chao Su |
source |
6 |
| PharmaSUG |
2019 |
ADME Study PK SDTM/ADaM And Graph |
Fan Lin |
source |
9 |
| PharmaSUG |
2019 |
An Automated, Metadata Approach to Electronic Dataset Submissions |
Janette Garner |
source |
8 |
| PharmaSUG |
2019 |
Begin with the End of Validation: Adapting QbD Approach in Statistical Programming to Achieve Quality and Compliance Excellence |
Linghui Zhang |
source |
8 |
| PharmaSUG |
2019 |
Best Practices for ISS/ISE Dataset Development |
Bharath Donthi,
Lingjiao Qi |
source |
9 |
| PharmaSUG |
2019 |
Clinical Development Standards for FDA Bioresearch Monitoring (BIMO) Submissions |
Denis Michel,
Julie Maynard |
source |
11 |
| PharmaSUG |
2019 |
Dataset Specifications: Recipes for Efficiency and Quality |
David A. Scocca |
source |
7 |
| PharmaSUG |
2019 |
Define-XML with ARM |
Lei Jing,
Chao Wang |
source |
8 |
| PharmaSUG |
2019 |
Developing Analysis & Reporting Standards For Pharmaco-Epidemiology Observational Studies |
Bo Zheng,
Xingshu Zhu |
source |
5 |
| PharmaSUG |
2019 |
Experiences in Building CDISC Compliant ADaM Dataset to Support Multiple Imputation Analysis for Clinical Trials |
Xiangchen (Bob) Cui |
source |
20 |
| PharmaSUG |
2019 |
Have You Met Define.xml 2.0? |
Christine McNichol |
source |
15 |
| PharmaSUG |
2019 |
Incremental Changes: ADaMIG v1.2 Update |
Nancy Brucken,
Brian Harris,
Terek Peterson,
Alyssa Wittle,
Deborah Goodfellow |
source |
8 |
| PharmaSUG |
2019 |
Information Requests During An FDA Review |
Hong Qi,
Lei Xu,
Mary N. Varughese |
source |
8 |
| PharmaSUG |
2019 |
ISS Challenges and Solutions for a Compound with Multiple Submissions in Parallel |
Aiming Yang |
source |
4 |
| PharmaSUG |
2019 |
Macro Templates - Industry Specific SAS Programming Standardization |
Tabassum Ambia |
source |
8 |
| PharmaSUG |
2019 |
Making Lab Toxicity Tables Less Toxic on Your Brain |
Lindsey Xie,
Jinlin Wang,
Jennifer Sun,
Rita Lai,
Richann J. Watson |
source |
13 |
| PharmaSUG |
2019 |
More Traceability: Clarity in ADaM Metadata and Beyond |
Wayne Zhong,
Richann J. Watson,
Daphne E. Ewing,
Jasmine Zhang |
source |
26 |
| PharmaSUG |
2019 |
Multiple Studies BIMO Submission Package - A Programmer's Perspective |
Ramanjulu Valluru,
Harsha Dyavappa |
source |
17 |
| PharmaSUG |
2019 |
Performing Analytics on Free-Text Data Fields: A Programer-s Wurst Nitemare |
Michael S Rimler,
Matt Pitlyk |
source |
18 |
| PharmaSUG |
2019 |
Practical Guidance for ADaM Dataset Specifications and Define.xml |
Jack Shostak |
source |
14 |
| PharmaSUG |
2019 |
Practical Guide for Creating ADaM Datasets in Cross-over Studies |
Neha Sakhawalkar,
Kamleshkumar Patel |
source |
10 |
| PharmaSUG |
2019 |
Practices in CDISC End-to-End Streamlined Data Processing |
Chengxin Li |
source |
14 |
| PharmaSUG |
2019 |
Process optimization for efficient and smooth e-data submissions to both FDA and PMDA |
Eri Sakai,
Malla Reddy Boda,
Akari Kamitani,
Yoshitake Kitanishi |
source |
13 |
| PharmaSUG |
2019 |
Project Management Fundamentals for Programmers and Statisticians |
Jennifer Sniadecki |
source |
19 |
| PharmaSUG |
2019 |
The Anatomy of Clinical Trials Data: A Beginner's Guide |
Venky Chakravarthy |
source |
14 |
| PharmaSUG |
2019 |
Timing is Everything: Defining ADaM Period, Subperiod and Phase |
Nancy Brucken |
source |
7 |
| PharmaSUG |
2019 |
Updates on validation of ADaM data |
Sergiy Sirichenko |
source |
9 |
| PharmaSUG |
2019 |
Useful SAS techniques in Efficacy Analysis for Oncology studies |
Joy Zeng |
source |
21 |
| PharmaSUG |
2019 |
Using CDISC Standards with an MDR for EDC to Submission Traceability |
Paul K. Slagle,
Eric Larson |
source |
4 |
| PharmaSUG |
2019 |
Value-Level Metadata Done Properly |
Sandra Minjoe,
Mario Widel |
source |
21 |
| PharmaSUG |
2019 |
What-s New in the SDTMIG v3.3 and the SDTM v1.7 |
Fred Wood |
source |
13 |
| PharmaSUG |
2019 |
When biomarker drives primary endpoint: An oncology case study of SDTM design using multiple myeloma. |
Girish Kankipati,
Bhargav Koduru |
source |
5 |
| PHUSE US |
2019 |
Approach of Programming Production Harmonized with Submission |
Chengxin Li |
source
presentation source |
6 |
| PHUSE US |
2019 |
Best Practices for the Preparation of the ISS/ISE Datasets [poster] |
Aatiya Zaidi,
Bhavin Busa |
source |
1 |
| PHUSE US |
2019 |
CDISC in Phase I/II Studies: Case Studies in Adopting Standards |
Emily Woolley,
Amber Randall Scharp |
source
presentation source |
7 |
| PHUSE US |
2019 |
CDISC Rules + FDA Requests + PMDA Requirements = Guaranteed Compliance? |
Deborah Goodfellow,
Mario Widel |
source |
9 |
| PHUSE US |
2019 |
Compliance Report for Patient Reported Outcomes |
Shu-Ching,
Christine S Teng |
source
presentation source |
8 |
| PHUSE US |
2019 |
Creating the Virologic Response ADaM Dataset |
Manjusha Alapati |
source
presentation source |
7 |
| PHUSE US |
2019 |
Creation of Define-XML v2.0 Using SAS Program and Pinnacle 21 |
Yan Lei,
Yongjiang Xu |
source
presentation source |
10 |
| PHUSE US |
2019 |
Effective Presentations of CTCAE-graded Laboratory Data |
William Coar,
Amber Randall |
source
presentation source |
7 |
| PHUSE US |
2019 |
Evolving CDISC to the Next Decades: The CDISC Proof of Concept |
Peter Van Reusel,
Samuel Hume |
source
presentation source |
3 |
| PHUSE US |
2019 |
Have You Met Define-XML v2.0? |
Christine McNichol |
source
presentation source |
12 |
| PHUSE US |
2019 |
High-quality Study Data Standards for Submission |
Majdoub Haloui,
Ellen L. Asam |
source
presentation source |
9 |
| PHUSE US |
2019 |
Implementing Imputation Rules and Creating Analysis Flags Following CDISC Guidelines |
Venkata Madhira,
Harish Yeluguri |
source
presentation source |
8 |
| PHUSE US |
2019 |
Incremental Changes: ADaMIG v1.2 Update |
Brian Harris,
Deborah Goodfellow |
source
presentation source |
6 |
| PHUSE US |
2019 |
Interactive Exploratory Analysis and Visualization for Late-phase Clinical Data |
Sheng-Wei Wang,
Casey Yang |
source
presentation source |
9 |
| PHUSE US |
2019 |
Metadata-based Auto-Programming Process - Part 2: Map Human Language to SAS Code by Natural Language Processing (NLP) |
Sumesh Kalappurakal,
Harry Chen |
source
presentation source |
11 |
| PHUSE US |
2019 |
Optimize PRO Data Analysis with an Interactive Approach |
Xiangyun Wang,
Elisabeth Piault-Louis |
source
presentation source |
8 |
| PHUSE US |
2019 |
Remotely Manage Your Team's Time and Tasks Efficiently |
Vara Prasad Reddy Sakampally |
source
presentation source |
5 |
| PHUSE US |
2019 |
Simplifying P21 Process for Define Creation |
Ghanshyam Jangid |
source
presentation source |
5 |
| PHUSE US |
2019 |
Simplifying the Integration Riddle |
Deepak Ananthan,
Karthik Raja Subbiah |
source
presentation source |
6 |
| PHUSE US |
2019 |
Striking a Balance: Adoption of Analysis Results Metadata (ARM) in Early Development Studies |
Janet Low,
Pranab K. Mitra |
source
presentation source |
6 |
| PHUSE US |
2019 |
Submission of Software Programs to Regulatory Agencies |
Maria Dalton |
source
presentation source |
10 |
| PHUSE US |
2019 |
Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis |
Priya Gopal |
source
presentation source |
12 |
| PHUSE US |
2019 |
ValueListDefs, MethodDefs and WhereClauses: How to Define Data Traceability in a Metadata Repository |
Judith Goud |
source
presentation source |
11 |
| PHUSE EU |
2018 |
A Learned Approach to CDISC Specifications |
Stephen M. Noga,
Brandon L. Welch,
Jeffrey M. Abolafia |
source
presentation source |
9 |
| PHUSE EU |
2018 |
Developing an End-to-End Standard and Automated Risk-based Monitoring Process |
Giuseppe Di Monaco,
Tim P. Williams |
source
presentation source |
11 |
| PHUSE EU |
2018 |
First Aid Kit for an Observational Study |
Yuliia Bahatska,
Vladlen Ivanushkin |
source
poster source |
4 |
| PHUSE EU |
2018 |
Generating Define-XML and Analysis Results Metadata Using Specifications, Datasets and TFL Annotation |
Mark Crangle |
source
presentation source |
13 |
| PHUSE EU |
2018 |
How to Write ADaM Specifications Like a Ninja |
Caroline Francis |
source
poster source |
5 |
| PHUSE EU |
2018 |
Implementation of a Metadata-based Approach to Statistical Planning, Analysis and Reporting |
Frank Freischlager,
Hanspeter Schnitzer |
source
presentation source |
7 |
| PHUSE EU |
2018 |
Implementation of Data Cut Off in Analysis of Clinical Trials |
Ann Croft |
source
presentation source |
13 |
| PHUSE EU |
2018 |
Incremental Changes: ADaMIG v1.2 Update |
Terek J. Peterson,
Brian Harris |
source
presentation source |
6 |
| PHUSE EU |
2018 |
Lessons Learned for Successful e-Study Data Submission to the PMDA towards the End of the Transitional Period |
Takashi Kitahara,
Ayako Noda |
source
presentation source |
12 |
| PHUSE EU |
2018 |
Optimizing the Traceability Method in ADaM Parallel Conversions |
Roxane Debrus |
source
presentation source |
15 |
| PHUSE EU |
2018 |
Practical Lessons Learned from Recent NDA and BLA Submissions to the FDA |
Carey G. Smoak,
Lisa Brooks |
source
presentation source |
5 |
| PHUSE EU |
2018 |
SAS and UNIX: Rerun Your Batches in a Smarter Way |
Yaroslav Haiovyi |
source
presentation source |
19 |
| PHUSE EU |
2018 |
SDTMIG v3.3: New Domains - New Benefits |
Nick De Donder |
source
presentation source |
6 |
| PHUSE EU |
2018 |
The "CDISC Stupidario" (the CDISC Nonsense) |
Angelo Pinazzi |
source
poster source |
11 |
| PHUSE EU |
2018 |
ValueListDefs, MethodDefs and WhereClauses: How to Define Data Traceability in a Metadata Repository |
Judith Goud |
source
presentation source |
11 |
| SESUG |
2018 |
Tips on Developing SDTM Datasets for Complex Long-Term Safety Studies |
Yunzhi Ling,
Helen Wang |
source |
7 |
| WUSS |
2018 |
CDISC in Phase I/II Studies: Approaches to adopting standards for CSR deliverables |
Emily Woolley,
Amber Randall |
source |
9 |
| PHUSE US |
2018 |
ADaM Intermediate Dataset: How to Improve Your Analysis Traceability |
Angelo Tinazzi,
Ashish Aggarwal |
source
presentation source |
12 |
| PHUSE US |
2018 |
Automate Analysis Result Metadata in the Define-XML v2.0 |
Hong Qi,
Larry Wu |
source
presentation source |
8 |
| PHUSE US |
2018 |
Automated Creation of Submission-Ready Artifacts |
Lourdes Devenney,
Silas McKee |
source
presentation source |
5 |
| PHUSE US |
2018 |
BIMO Listings - Check That Off Your NDA To-Do List |
Charanjit Kahlon,
Bhavin Busa |
source |
7 |
| PHUSE US |
2018 |
Comparing and Contrasting Differences between the PHUSE SDSP and CBER Checklist |
Janet Low,
Pritesh Solanki |
source
presentation source |
5 |
| PHUSE US |
2018 |
Cue the Word - QC - All You Need to Know! |
Subha Jamburajan,
Nancy Haeusser |
source
presentation source |
6 |
| PHUSE US |
2018 |
Don't Sweat It! Consider Taking the Risk Out of your Outsourced Deliverables |
Jennifer True,
Nancy Haeusser |
source
presentation source |
4 |
| PHUSE US |
2018 |
Generating Define.xml v2.0 and Analysis Result Metadata using ADaM Specifications ADaM Datasets and TFL Shells Annotation |
Mark Crangle,
Hima Bhatia |
source
presentation source |
9 |
| PHUSE US |
2018 |
Harnessing the Web to Streamline Statistical Programming Processes |
Daniel J. Boisvert,
Gordon Schantz |
source
presentation source |
8 |
| PHUSE US |
2018 |
How To Derive Parameters At ADaM Level For Generating Yearly Interval Exposure Tables [presentation] |
Geetha Kesireddy |
source |
10 |
| PHUSE US |
2018 |
How to Prepare High Quality Metadata for Submission [presentation] |
Varun Debbeti |
source |
31 |
| PHUSE US |
2018 |
Lead Programmer Needs Help: Dedicated Programming Project Manager to the Rescue! |
Smitha Nathan,
Bhavin Busa |
source |
5 |
| PHUSE US |
2018 |
Patterns Emerging from Chaos |
Alan Cantrell |
source
presentation source |
5 |
| PHUSE US |
2018 |
Ready Set Go: Planning and Preparing a CDISC Submission |
Maria Dalton |
source
presentation source |
11 |
| PHUSE US |
2018 |
Secure Data Office: An Independent Team that Can Come to the Rescue in Blinded Trials |
Annelies Van Zeveren,
Yana Hoorne |
source
presentation source |
9 |
| PHUSE US |
2018 |
Step Up Your ADaM Compliance Game |
Ramesh Ayyappath |
source
presentation source |
5 |
| PHUSE US |
2018 |
Using a Waiver Process as a Change-Control Tool from ADaM Standards Governance |
Karin LaPann |
source
presentation source |
6 |
| PHUSE US |
2018 |
Want Submission-Ready Datasets Package from the Get-Go? |
Kishore Pothuri,
Bhavin Busa |
source |
7 |
| PharmaSUG |
2018 |
A Macro to Create Program Inventory for Analysis Data Reviewer's Guide |
Xianhua Zeng |
source |
6 |
| PharmaSUG |
2018 |
A SAS Macro to Create Validation Summary of Dataset Report |
Zemin Zeng |
source |
6 |
| PharmaSUG |
2018 |
A Statistician's Guide to Leadership and Success |
Heather Murphy |
source |
5 |
| PharmaSUG |
2018 |
A time saving approach to track data issues |
Aishhwaryapriya Elamathivadivambigai |
source |
8 |
| PharmaSUG |
2018 |
ADaM for Medical Devices: Extending the Current ADaM Structures |
Julia Yang,
Sandra Minjoe |
source |
7 |
| PharmaSUG |
2018 |
ADaM Structures for Integration: A Preview |
Deborah J. Bauer,
Kimberly Minkalis,
Wayne Zhong |
source |
14 |
| PharmaSUG |
2018 |
ADINTDT and ADTTE for Survival Sweep in Oncology Studies |
Christine S Teng,
Wenyu Hu |
source |
6 |
| PharmaSUG |
2018 |
Automation of STDM dataset integration and ADaM dataset formation |
Rinki Jajoo,
William Wei |
source |
11 |
| PharmaSUG |
2018 |
Challenges & Strategies in PKPD Programming |
Jing Su,
Jiannan Kang |
source |
6 |
| PharmaSUG |
2018 |
Challenges for Implementing Study Data Standardization Plan (SDSP) in Legacy Data Submission |
Shengfeng Ho |
source |
9 |
| PharmaSUG |
2018 |
Challenges in Implementing Device Related ADaM and SDTM Standards in a Drug-Device Study |
Wenying Tian,
Maureen Maunsell,
Karin LaPann |
source |
9 |
| PharmaSUG |
2018 |
Common Data Related Review Issues and Prevention: A Statistical Reviewer's Thoughts |
Huanyu Chen |
source |
18 |
| PharmaSUG |
2018 |
Complying with the ADaM Compliance Rules |
Alyssa M. Wittle,
Steven R. Kirby |
source |
4 |
| PharmaSUG |
2018 |
Creating an ADaM Data Set for Correlation Analyses |
Chad W. Melson |
source |
11 |
| PharmaSUG |
2018 |
Doctor-s 'Prescription' to Reengineer Process of Pinnacle21 Community Version Friendly ADaM Developm |
Aakar Shah,
Tracy Sherman |
source |
9 |
| PharmaSUG |
2018 |
eSubmission - Are you really Compliant? |
Majdoub Haloui,
Suhas R. Sanjee |
source |
5 |
| PharmaSUG |
2018 |
Family of PARAM***: PARAM, PARAMCD, PARAMN, PARCATy(N), PARAMTYPE |
Kamleshkumar Patel |
source |
12 |
| PharmaSUG |
2018 |
Generating Define.xml from Pinnacle 21 Validator |
Pinky Anandani |
source |
15 |
| PharmaSUG |
2018 |
How PK and PD analyses drive dataset designs |
David Radtke,
Brian A. Moser |
source |
7 |
| PharmaSUG |
2018 |
Implementation of ADaM Basic Data Structure on Genetic Variation Data for Pharmacogenomics Studies |
Linghui Zhang |
source |
10 |
| PharmaSUG |
2018 |
Implementation of Data Cut Off in Analysis of Clinical Trials |
Mei Dey |
source |
15 |
| PharmaSUG |
2018 |
It's all about getting the Source and Codelist Implementation right for ADaM Define.xml v2.0 |
Supriya Davuluri |
source |
11 |
| PharmaSUG |
2018 |
No News Is Good News: A Macro to Reveal the Untold Normal Lab Results |
Ming Yan |
source |
7 |
| PharmaSUG |
2018 |
Programmer's Guide for OSI Deliverables - Creation of Site Level Summary Dataset and Automation of BIMO Listins Generation |
Charanjit Kahlon,
Kristie Kooken,
Bhavin Busa,
Dharmendra Tirumalasetti |
source |
10 |
| PharmaSUG |
2018 |
Review programs used for submission and their input to the define-XML 2.0 |
Ari Siggaard Knoph,
Morten Hasselstrm Jensen,
Bo Sølgaard Andersen |
source |
11 |
| PharmaSUG |
2018 |
Some Common Programming Errors and Possible Solutions That Could Impact a Successful NDA/BLA |
Amos Shu |
source |
5 |
| PharmaSUG |
2018 |
Speed Up SDTM/ADaM Dataset Development with If-Less Programming |
Lei Zhang,
John Lu |
source |
17 |
| PharmaSUG |
2018 |
Statistical Programming: Revolution, Evolution, or Status Quo? |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source |
9 |
| PharmaSUG |
2018 |
Telling Stories with Jupyter Notebook |
Kevin Lee |
source |
14 |
| PharmaSUG |
2018 |
To Error is Human: An Overview of Human Errors in SAS Programming and How to Mitigate Them |
Nagadip Rao |
source |
9 |
| PharmaSUG |
2018 |
Traceability: Some Thoughts and Examples for ADaM Needs |
Richann J. Watson,
Kent Letourneau,
Wayne (Weizhen) Zhong,
Sandra Minjoe |
source |
18 |
| PharmaSUG |
2018 |
Want Submission-Ready Datasets Package from the Get-Go? |
Kishore Pothuri,
Bhavin Busa |
source |
8 |
| PharmaSUG |
2018 |
Watch Out For Blind Spots While Keeping Up With the Speed of Evolving Standards and Regulations |
Srinivas Veeragoni |
source |
14 |
| SGF |
2018 |
Application of Support Vector Machine Modeling and Graph Theory Metrics for Disease Classification |
Jessica Rudd |
source |
10 |
| SGF |
2018 |
The Anatomy of Clinical Trials Data: A Beginner's Guide |
Venky Chakravarthy |
source |
14 |
| SESUG |
2017 |
A Data-Driven Approach for Generating Define.xml v2.0 using ADaM Specifications and ADaM Datasets |
Jaskaran Sing Gill,
Hima Bhatia,
ICON Plc |
source |
8 |
| SESUG |
2017 |
An Introduction to Visit Window Challenges and Solutions |
Mai Ngo |
source |
6 |
| SESUG |
2017 |
DE-Identifying Data when Sharing Clinical Data |
Pushpa Saranadasa |
source |
5 |
| SESUG |
2017 |
Everyone can use a little Currency - when dependent data set updates silently make your analysis data set out of date |
Scott Worrell |
source |
8 |
| SESUG |
2017 |
Streamlining ADaM Dataset Specifications |
Hunter Vega |
source |
6 |
| SESUG |
2017 |
Timing Variables In Clinical Trials: Avoiding Common Mistakes And Dealing With Unforeseen Issues |
Gregory Weller |
source |
4 |
| PHUSE EU |
2017 |
A Labour-saving SAS Macro fro Programmed Patient Narratives |
Vineeth Kurnala,
Prafulla Girase |
source
presentation source |
9 |
| PHUSE EU |
2017 |
ADaM Mapping - KeyConsiderations forMetadata Driven Realization |
Elenea Gathe |
source |
12 |
| PHUSE EU |
2017 |
ADAM Programming - The Good, The Bad and The Ugly |
Pam Howard |
source
presentation source |
8 |
| PHUSE EU |
2017 |
Adverse Events Data Over Time |
Kriss Harris |
source
presentation source |
11 |
| PHUSE EU |
2017 |
An FDA Submission Experience Using the CDISC Standards |
Angelo Tinazzi,
Cédric Marchand |
source
presentation source |
15 |
| PHUSE EU |
2017 |
Automatic Creation of Define .xml for ADaM: A Fast Way Approach, Starting from ADaM Metadata |
Andreas Parodi,
Dimitri Petratchenko |
source
presentation source |
7 |
| PHUSE EU |
2017 |
CDISC Transport Standards - A Glance |
Edwin Ponraj Thangarajan,
Giri Balasubramanian |
source
presentation source |
14 |
| PHUSE EU |
2017 |
Constrain your Terminology - Use Integrity Constraints to Validate your Data |
Sven Greiner |
source
presentation source |
9 |
| PHUSE EU |
2017 |
Consuming Your Metadata for a Healthy Mapping |
Alan Cantrell,
Julius Kusserow |
source
presentation source |
4 |
| PHUSE EU |
2017 |
Detecting Treatment Emergent Adverse Events (TEAEs) |
Matthias Lehrkamp |
source
presentation source |
12 |
| PHUSE EU |
2017 |
Implementation of CDISC ADaM and Pharmacodynamics |
Françoise Frérart,
Joanna Magielse |
source
presentation source |
5 |
| PHUSE EU |
2017 |
Job of Jobs |
Kris Lauwers,
Raphael Noirfalise |
source
presentation source |
3 |
| PHUSE EU |
2017 |
Reducing Dataset Merges with Data Driven Formats |
Paul Grimsey |
source
presentation source |
8 |
| PHUSE EU |
2017 |
SDTM-ADaM Hybrid: Supermodel or Frankenstein? |
Kenneth Stoltzfus |
source
presentation source |
8 |
| PHUSE EU |
2017 |
The Secure Data Office Concept |
Annemie Van Dijck |
source
presentation source |
9 |
| PHUSE EU |
2017 |
Worst CDISC Implementation Processes - How to Avoid Some Very Basic Mistakes in SDTM ADaM Define |
Hannes Engberg Reader,
Michale Riech |
source
presentation source |
10 |
| MWSUG |
2017 |
ADQRS: Basic Principles for Building Questionnaire, Rating and Scale Analysis Datasets |
Nancy Brucken,
Karin LaPann |
|
6 |
| MWSUG |
2017 |
Mapping MRI data to SDTM and ADaM |
Lingling Xie,
Xiaoqi Li |
|
10 |
| PharmaSUG CN |
2017 |
Constructive Practice of Generating ADaM Datasets |
Amos Shu |
|
7 |
| PharmaSUG |
2017 |
A Guide To Programming Patient Narratives |
Renuka Tammisetti,
Karthika Bhavadas |
source |
6 |
| PharmaSUG |
2017 |
ADaM Compliance - Validating your Specifications |
Trevor Mankus,
Kent Letourneau |
source |
9 |
| PharmaSUG |
2017 |
ADaM Grouping: Groups, Categories, and Criteria. Which Way Should I Go? |
Jack Shostak |
source |
12 |
| PharmaSUG |
2017 |
ADQRS: Basic Principles for Building Questionnaire, Rating and Scale Analysis Datasets |
Nancy Brucken,
Karin LaPann |
source |
6 |
| PharmaSUG |
2017 |
Adverse Event Data over Time |
Kriss Harris |
source |
11 |
| PharmaSUG |
2017 |
An Efficient Solution to Efficacy ADaM Design and Implementation |
Chengxin Li,
Zhongwei Zhou |
source |
7 |
| PharmaSUG |
2017 |
Awareness from Electronic Data Submission to PMDA and FDA -- Lesson & Learnt from hands-on experiences -- |
Yuichi Nakajima,
Takashi Kitahara,
Ryan Hara |
source |
12 |
| PharmaSUG |
2017 |
Challenge for Dramatic Streamlining of TLFs Creation Process with SAS and Java |
Yohei Takanami,
Fumihiro Yamasaki |
source |
8 |
| PharmaSUG |
2017 |
Clarifications About ADaM Implementation Provided in ADaMIG Version 1.1 |
John K. Troxell |
source |
5 |
| PharmaSUG |
2017 |
Creating Define-XML version 2 including Analysis Results Metadata with the SAS Clinical Standards Toolkit |
Lex Jansen |
source |
31 |
| PharmaSUG |
2017 |
Data Monitoring Committee Report Programming: Considering a Risk-Based Approach to Quality Control |
Amber Randall,
Bill Coar |
source |
9 |
| PharmaSUG |
2017 |
Dear Dave, Please See the .LST File for Our Validation Differences. Thanks, Bad Validation Programmer |
Tracy Sherman,
David W. Carr,
Brian P. Fairfield-Carter |
source |
9 |
| PharmaSUG |
2017 |
Deriving Rows in CDISC ADaM BDS Datasets |
Sandra Minjoe |
source |
12 |
| PharmaSUG |
2017 |
Developing ADaM Dataset for Cardiovascular Outcome Studies |
Joanne C. Zhou,
Rakesh Kumar,
David L. Wade,
David C. Chen |
source |
4 |
| PharmaSUG |
2017 |
Documenting Traceability for the FDA: Clarifying the Legacy Data Conversion Plan & Introducing the Study Data Traceability Guide |
David C. Izard,
Kristin Kelly,
Jane Lozano |
source |
9 |
| PharmaSUG |
2017 |
Everyone can use a little Currency - when dependent data set updates silently make your analysis data set out of date |
Scott Worrell |
source |
8 |
| PharmaSUG |
2017 |
Good Programming Practices at Every Level |
Maria Dalton |
source |
6 |
| PharmaSUG |
2017 |
Gray Areas of ADaM and Ways to Provide Color [presentation] |
Susan J. Kenny,
Sandra Minjoe,
Nate Freimark,
Jack Shostak,
John K. Troxell,
Deborah J. Bauer |
source |
38 |
| PharmaSUG |
2017 |
Harmonizing CDISC Data Standards across Companies: A Practical Overview with Examples |
Keith Shusterman,
Prathima Surabhi,
Binoy Varghese |
source |
6 |
| PharmaSUG |
2017 |
Lead Programmer Needs Help: Dedicated Programming Project Manager to the Rescue! |
Gloria Boye,
Aparna Poona,
Bhavin Busa |
source |
7 |
| PharmaSUG |
2017 |
Multi-Dimensional Arrays: Add Derived Parameters |
Siddharth Kumar Mogra |
source |
7 |
| PharmaSUG |
2017 |
Overview and Application of the HCV Vertical Resistance Analysis Template |
Yan Xie |
source |
5 |
| PharmaSUG |
2017 |
Preparing Analysis Data Model (ADaM) Data Sets and Related Files for FDA Submission |
Sandra Minjoe |
source |
12 |
| PharmaSUG |
2017 |
Programming Efficiency in the Creation of ADaM BDS Datasets |
Ellen (Zihui) Lin |
source |
11 |
| PharmaSUG |
2017 |
Quality Check your CDISC Data Submission Folder Before It Is Too Late! |
Bhavin Busa |
source |
9 |
| PharmaSUG |
2017 |
The Benefits of Traceability Beyond Just From SDTM to ADaM in CDISC Standards |
Maggie Ci Jiang |
source |
8 |
| PharmaSUG |
2017 |
The Road Not Taken: SAS for Pharmacometrics |
Vishak Subramoney,
Sree Harsha Sreerama Reddy |
source |
4 |
| SGF |
2017 |
Deriving Rows in CDISC ADaM BDS Data Sets Using SAS DATA Step Programming |
Sandra Minjoe |
source |
17 |
| SGF |
2017 |
Preparing Analysis Data Model (ADaM) Data Sets and Related Files for FDA Submission with SAS |
Sandra Minjoe,
John K. Troxell |
source |
12 |
| SGF |
2017 |
Quality Control Programming: A Lost Art? |
Amber Randall,
Bill Coar |
source |
15 |
| SGF |
2017 |
Using SAS to Estimate Rates of Disease from Nationally Representative Databases |
Jessica Rudd |
source
pdf |
10 |
| SESUG |
2016 |
SDTM What? ADaM Who? A Programmer's Introduction to CDISC |
Venita DePuy |
source |
9 |
| PHUSE EU |
2016 |
Add Derived Parameters with Multi-dimensional Arrays |
Siddharth Kumar |
source
presentation source |
5 |
| PHUSE EU |
2016 |
Analysis Datasets for Baseline Characteristics and Exposure Time for Multi-stage Clinical Trials |
Kimberly Umans,
Katherine Riester |
source
presentation source |
5 |
| PHUSE EU |
2016 |
Analysis Results Metadata...Are We There Yet? |
Carla Santillán |
source
presentation source |
10 |
| PHUSE EU |
2016 |
Automating ADaM |
Helen Hart,
Christof Binder |
source
presentation source |
3 |
| PHUSE EU |
2016 |
Boosting the Efficiency of Data Review by using SAS Integration Technologies and VBA |
Giuseppe Di Monaco |
source
presentation source |
9 |
| PHUSE EU |
2016 |
Efficiently Converting Datasets to Vertical Structure using Metadata |
Thevaki Mahadevan |
source
presentation source |
6 |
| PHUSE EU |
2016 |
From SDTM to Displays, through ADaM & Analysis Results Metadata, a Flight on Board Metadata Airlines |
Omar Sefiani,
Stéphane Bouget |
source
presentation source |
10 |
| PHUSE EU |
2016 |
Generating Analysis Results and Metadata - Report from a PHUSE CS Project |
Marc Andersen,
Marcelina Hungria,
Suhas R. Sanjee |
source
presentation source |
10 |
| PHUSE EU |
2016 |
Increasing Work Group Transparency: ADaMIG v1.2 Update and New Team Working Process Review |
Terek J. Peterson,
Brian Harris |
source
presentation source |
8 |
| PHUSE EU |
2016 |
Japanese Electronic Submission in CDISC Formats |
Takashi Kitahara |
source
presentation source |
8 |
| PHUSE EU |
2016 |
Linking Metadata from CDASH to ADaM |
João Gonçalves |
source
presentation source |
6 |
| PHUSE EU |
2016 |
On the Fast Lane to a Successful Submission - A Lead Programmer's Guide to Efficient, High-quality Submission Programming Deliverables |
Michael Reich,
Hannes Engberg Raeder |
source
presentation source |
9 |
| PHUSE EU |
2016 |
Pattern-based MDR: Towards High-quality Data Standards |
Alan Cantrell,
Julius Kusserow |
source
presentation source |
7 |
| PHUSE EU |
2016 |
Standard Safety Visualisation Set-up Using Spotfire |
Michaela Mertes |
source
presentation source |
10 |
| PHUSE EU |
2016 |
The TFL Workbench: Tools to Standardise and Accelerate Table, Figure and Listing (TFL) Programming |
Iain Humphreys,
Hansjörg Frenzel |
source
presentation source |
10 |
| PHUSE EU |
2016 |
To Create Define-XML Using - XML and the OpenCDISC Validator [presentation] |
Murali Neela |
source |
17 |
| PHUSE EU |
2016 |
Upstream with Your Statistician and a Data Visualisation Paddle |
Nick Cowans |
source
presentation source |
6 |
| PHUSE EU |
2016 |
Using Metadata to Drive Standards, Speed, Consistency and Quality in Reporting |
Shafi Chowdhury,
Daniel J. Boisvert |
source
presentation source |
6 |
| PHUSE EU |
2016 |
What Auditors Want |
Angelo Tinazzi,
Cédric Marchand |
source
presentation source |
8 |
| MWSUG |
2016 |
A SAS Macro to Create a Data Dictionary with Ease |
Amy Gravely,
Barbara Clothier |
|
7 |
| MWSUG |
2016 |
How to Create Sub-sub Headings in PROC REPORT and Why You Might Want to: Thinking about Non-traditional Uses of PROC REPORT |
Amy Gravely,
Barbara Clothier |
|
5 |
| MWSUG |
2016 |
How to Speed Up Your Validation Process Without Really Trying |
Alice M. Cheng,
Mike Wise |
|
22 |
| PharmaSUG CN |
2016 |
Proposal for Streamlining the SDRG and ADRG Authoring Process [presentation] |
Stanley Wei |
|
1 |
| WUSS |
2016 |
A Well-Formatted and Easy-to-Navigate Solution for Submitting SAS Source Code in NDA Submission |
Jeff Xia,
Lugang Larry Xie |
source |
7 |
| WUSS |
2016 |
Are you ready for Dec 17th, 2016 - CDISC compliant data submission? |
Kevin Lee |
source |
6 |
| WUSS |
2016 |
Building Better ADaM Datasets Faster With If-Less Programming |
Lei Zhang |
source |
17 |
| WUSS |
2016 |
How to Speed Up Your Validation Process Without Really Trying |
Alice M. Cheng,
Mike Wise,
Justina M. Flavin |
source |
20 |
| PharmaSUG |
2016 |
A Practical Approach to Re-sizing Character Variable Lengths for FDA Submission Datasets (both SDTM and ADaM) |
Xiangchen (Bob) Cui,
Min Chen |
source |
19 |
| PharmaSUG |
2016 |
AE: An Essential Part of Safety Summary Table Creation |
Rucha Landge |
source |
12 |
| PharmaSUG |
2016 |
Creating Define-XML version 2 including Analysis Results Metadata with the SAS Clinical Standards Toolkit |
Lex Jansen |
source |
29 |
| PharmaSUG |
2016 |
Creating Time to Event ADaM Dataset for a Complex Efficacy Endpoint in Multiple Sclerosis Therapeutic Area |
Ittai Rambach |
source |
8 |
| PharmaSUG |
2016 |
Don-t Agonize, Organize: Maximizing efficiency and effectiveness of SAS Programming in Clinical Trials projects, by using Project Management Organizing Methodologies |
Shefalica Chand |
source |
8 |
| PharmaSUG |
2016 |
Good versus Better SDTM: Data Listings |
Mario Widel,
Henry B. Winsor |
source |
11 |
| PharmaSUG |
2016 |
Implementation of ADaM Basic Data Structure for Cross-over Studies |
Songhui Zhu |
source |
10 |
| PharmaSUG |
2016 |
Importance of Niche Provider for Successful NDA Submission: Rescue Case Study |
Aparna Poona,
Bhavin Busa,
Tim Southwick |
source |
9 |
| PharmaSUG |
2016 |
New Features in Define-XML V2.0 and Its Impact on SDTM/ADaM Specifications |
Hang Pang |
source |
12 |
| PharmaSUG |
2016 |
Preparing Legacy Format Data for Submission to the FDA - When & Why Must I Do It, What Guidance Should I Follow? |
David C. Izard |
source |
11 |
| PharmaSUG |
2016 |
Preparing the Data to Ensure Correct Calculation of Relative Risk |
Ravi Kankipati,
Abhilash Chimbirithy |
source |
13 |
| PharmaSUG |
2016 |
Programming checks: Reviewing the overall quality of the deliverables without parallel programming |
Shailendra Phadke,
Veronika Csom |
source |
8 |
| PharmaSUG |
2016 |
Programming Support for Exposure-Response Analysis in Oncology Drug Development |
Peter Lu,
Hong Yan |
source |
8 |
| PharmaSUG |
2016 |
Results-Level Metadata: What, How, and Why |
Frank C. DiIorio,
Jeffrey M. Abolafia |
source |
11 |
| PharmaSUG |
2016 |
Strategic Considerations for CDISC Implementation |
Amber Randall,
William Coar |
source |
6 |
| PharmaSUG |
2016 |
To IDB or Not to IDB: That is the Question |
Kjersten Offenbecker,
Beth Seremula |
source |
7 |
| PharmaSUG |
2016 |
Working with Composite Endpoints: Constructing Analysis Data |
Pushpa Saranadasa |
source |
7 |
| SGF |
2016 |
How to Speed Up Your Validation Process Without Really Trying |
Alice M. Cheng,
Justina M. Flavin,
Michael Wise |
source |
20 |
| PHUSE EU |
2015 |
A Modularised Approach to the Development of a Data Science Tool |
Guiseppe Di Monaco |
source
presentation source |
10 |
| PHUSE EU |
2015 |
ADaM - Our Experience |
Rob Wartenhorst |
source
presentation source |
5 |
| PHUSE EU |
2015 |
Analysing the Role of a Lead Programmer |
Ester Schoeman |
source
presentation source |
9 |
| PHUSE EU |
2015 |
Automated generation of program templates with metadata based specification documents for integrated analysis |
Thomas Wollseifen |
source
presentation source |
11 |
| PHUSE EU |
2015 |
Errors Beyond Open CDISC Validator |
Gayatri Karkera,
Nehan Mohan |
source
presentation source |
4 |
| PHUSE EU |
2015 |
Introduction to GPP with Hints and Tips to Make them Second Nature |
Alexandra Marquat,
Shafi Chowdhury |
source
presentation source |
7 |
| PHUSE EU |
2015 |
Results-Level Metadata: What, How, and Why |
Frank C. DiIorio,
Jeffrey M. Abolafia |
source
presentation source |
11 |
| PHUSE EU |
2015 |
Standardised Reporting Using ADaM (STREAM Model) |
Ankur Chakraborty |
source
presentation source |
2 |
| PHUSE EU |
2015 |
The Highs, Lows and Lessons of a First-Time Study Lead |
Bethan Thomas |
source
presentation source |
7 |
| SESUG |
2015 |
Reporting of treatment emergent adverse events based on pooled data Analysis or Country Specific Submissions: A case study |
Sheetal Shiralkar |
source |
8 |
| SESUG |
2015 |
Where Did My Students Go? |
Stephanie R. Thompson |
source |
4 |
| WUSS |
2015 |
How to Speed Up Your Validation Process Without Really Trying |
Alice M. Cheng |
source |
23 |
| PharmaSUG CN |
2015 |
Hands-On ADaM ADAE Development |
Sandra Minjoe |
|
7 |
| PharmaSUG CN |
2015 |
Managing the analysis programming effort for an NDA submission |
Yu Cheng,
Quan Zhou |
|
8 |
| PharmaSUG CN |
2015 |
Tips for efficient CDISC eCRT production |
Lanting Li,
Yu Zhu,
Yuejuan Meng,
Huan Zhu |
|
11 |
| PharmaSUG |
2015 |
A Methodology of Laboratory Data Reporting of Potentially Clinical Significant Abnormality (PCSA) for Clinical Study Report |
Xiangchen (Bob) Cui,
Min Chen |
source |
21 |
| PharmaSUG |
2015 |
A SAS Macro Tool to Automate Generation of Define.xml V2.0 from ADaM Specification for FDA Submission |
Min Chen,
Xiangchen (Bob) Cui |
source |
28 |
| PharmaSUG |
2015 |
ADaM Example for a Complex Efficacy Analysis Dataset |
Milan Mangeshkar,
Sandra Minjoe |
source |
8 |
| PharmaSUG |
2015 |
ADDL Model for Device Analysis |
Priya Gopal |
source |
6 |
| PharmaSUG |
2015 |
Advantages and Disadvantages of Two Commonly Used CRO Resourcing Models in the Pharmaceutical SAS Programming Environment |
Ying (Evelyn) Guo,
Mark Matthews |
source |
7 |
| PharmaSUG |
2015 |
Begin with the End in Mind - Using FDA Guidance Documents as Guideposts when Planning, Delivering and Archiving Clinical Trials |
David C. Izard |
source |
12 |
| PharmaSUG |
2015 |
Challenges in Developing ADSL with Baseline Data |
Hongyu Liu,
Hang Pang |
source |
6 |
| PharmaSUG |
2015 |
Considerations in Conforming Data from Multiple Implantable Medical Devices to CDISC Standards Using SAS |
Julia Yang |
source |
9 |
| PharmaSUG |
2015 |
Implementing Various Baselines for ADaM BDS datasets |
Songhui Zhu |
source |
7 |
| PharmaSUG |
2015 |
Improving Data Quality - Missing Data Can Be Your Friend! |
Julie Chen |
source |
12 |
| PharmaSUG |
2015 |
It Depends On Your Analysis Need |
Sandra Minjoe |
source |
10 |
| PharmaSUG |
2015 |
Prospecting for Great Programmers - Advice from a Hiring Manger to Make You a Solid Gold Addition to the Team |
Christopher C. Hurley,
James Zuazo |
source |
6 |
| PharmaSUG |
2015 |
Team-work and Forensic Programming: Essential Foundations of Indestructible Projects |
Brian P. Fairfield-Carter |
source |
14 |
| PharmaSUG |
2015 |
The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future |
Shelley Dunn,
Ed Lombardi |
source |
9 |
| PharmaSUG |
2015 |
The Implementation of Display Auto-Generation with Analysis Results Metadata Driven Method |
Chengxin Li |
source |
11 |
| PharmaSUG |
2015 |
Tips on Creating a Strategy for a CDISC Submission |
Rajkumar Sharma |
source |
5 |
| PharmaSUG |
2015 |
Two different use cases to obtain best responses using RECIST 1.1: SDTM and ADaM |
Kevin Lee,
Vikash Jain |
source |
17 |
| PharmaSUG |
2015 |
What is the "ADAM OTHER" Class of Datasets, and When Should it be Used? |
John K. Troxell |
source |
5 |
| SGF |
2015 |
Where Did My Students Go? |
Stephanie R. Thompson |
source |
4 |
| SESUG |
2014 |
SDTM What? ADaM Who? A Programmer's Introduction to CDISC |
Venita DePuy |
source |
9 |
| PHUSE EU |
2014 |
ADaM Conversions: The Good, The Bad and The Ugly |
Carla Santillán,
Jessica Minuke |
source
presentation source |
11 |
| PHUSE EU |
2014 |
ADaM Standards: What's New? |
Gavin Winpenny |
source
presentation source |
9 |
| PHUSE EU |
2014 |
Challenges of Different MedDRA Versions for Integrated Data and Databases |
Peter Bonata |
source
presentation source |
8 |
| PHUSE EU |
2014 |
Challenges with the Interpretation of CDIOSC - Who Can We Trust? |
Linda Palm Simonsson |
source
presentation source |
10 |
| PHUSE EU |
2014 |
Data Challenges in Adaptive Trials |
Claudio Garutti |
source
presentation source |
5 |
| PHUSE EU |
2014 |
Every Study is Special! - Governing Data Standards |
Chris Price,
Elizabeth Nicol |
source
presentation source |
12 |
| PHUSE EU |
2014 |
Frequency Tables - Aspects to Consider |
Katja Glass |
source
presentation source |
10 |
| PHUSE EU |
2014 |
Implementation of CDISC ADaM in the Pharmacokinetics Department |
Joanna Magielse,
Tineke Callant |
source
presentation source |
6 |
| PHUSE EU |
2014 |
My Transition From Placement Student to Permanent Employee Within the Same Company |
Robyn Rosser |
source
presentation source |
4 |
| PHUSE EU |
2014 |
The On-Going Evolutionary Changes of our Industry [presentation] |
Christian Mueller |
source |
34 |
| PHUSE EU |
2014 |
Traceability: Plan Ahead for Future Needs |
Sandra Minjoe |
source
presentation source |
8 |
| PharmaSUG CN |
2014 |
Design and Construct Efficacy Analysis Datasets in Later Phase Oncology Study |
Huadan Li,
Changhong Shi |
|
9 |
| PharmaSUG CN |
2014 |
From Coal Mining to Data Mining: Advancing Programming Management for Clinical Projects with Text Analytics |
Zhouming Sun |
|
10 |
| PharmaSUG CN |
2014 |
Submission of Pharmacokinetics (PK) Data in a CDISC Compliant Format |
Yu Zhu |
|
9 |
| WUSS |
2014 |
TLF Validation Etiquette:What to Say, When to Say, How to Say, Why to Say |
Karen Walker |
source |
10 |
| PharmaSUG |
2014 |
A Macro to Create Occurrence Flags for Analysis Datasets |
Ed Lombardi |
source |
4 |
| PharmaSUG |
2014 |
A Road Map to Successful CDISC ADaM Submission to FDA: Guidelines, Best Practices & Case Studies |
Vikash Jain,
Sandra Minjoe |
source |
9 |
| PharmaSUG |
2014 |
An ADaM Interim Dataset for Time-to-Event Analysis Needs |
Tom Santopoli,
Kimberly Minkalis,
Sandra Minjoe |
source |
9 |
| PharmaSUG |
2014 |
Applying ADaM BDS Standards to Therapeutic Area Ophthalmology |
Songhui Zhu |
source |
10 |
| PharmaSUG |
2014 |
Automation of ADAM Dataset Creation with a Retrospective, Prospective and Pragmatic Process |
Karin LaPann,
Terek J. Peterson |
source |
6 |
| PharmaSUG |
2014 |
CDISC Electronic Submission |
Kevin Lee |
source |
6 |
| PharmaSUG |
2014 |
Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS |
Karin LaPann,
Terek J. Peterson |
source |
20 |
| PharmaSUG |
2014 |
Common Variables in Adverse Event and Exposure analysis datasets specific for Oncology clinical trials |
Haridasan Namboodiri |
source |
11 |
| PharmaSUG |
2014 |
Developing ADaM Specifications to Embrace Define-XML 2.0.0 Requirements |
Lin Yan |
source |
10 |
| PharmaSUG |
2014 |
Effective Use of Metadata in Analysis Reporting |
Jeffrey M. Abolafia |
source |
9 |
| PharmaSUG |
2014 |
Hands-On ADaM ADAE Development |
Sandra Minjoe,
Kimberly Minkalis |
source |
7 |
| PharmaSUG |
2014 |
The New Tradition: SAS Clinical Data Integration |
Vincent J. Amoruccio,
Janet E. Stuelpner |
source |
18 |
| PharmaSUG |
2014 |
TLF Validation Etiquette:What to Say, When to Say, How to Say, Why to Say |
Karen Walker |
source |
10 |
| SGF |
2014 |
Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS |
Karin LaPann,
Terek J. Peterson |
source |
19 |
| SGF |
2014 |
Converting Clinical Database to SDTM: The SAS Implementation |
Hong Chen |
source |
5 |
| WUSS |
2013 |
Building a Controlled Statistical Programming Environment |
Wayne F. Woo |
source |
10 |
| WUSS |
2013 |
Converting Electronic Medical Records Data into Practical Analysis Dataset |
Irena Stijacic Cenzer,
Mladen Stijacic,
Sei J. Lee |
source |
6 |
| PHUSE EU |
2013 |
ADaM Datasets - Standard and Submission Ready |
Karin Fleischer Steffensen |
source
presentation source |
6 |
| PHUSE EU |
2013 |
ADaM Standards - Organising the Unorganised |
Heike Reichert |
source
presentation source |
7 |
| PHUSE EU |
2013 |
Bringing Skeletons out of the Closet |
Parag Naithani |
source
presentation source |
10 |
| PHUSE EU |
2013 |
Descriptive Summary Tables Made Easy |
Shafi Chowdhury,
Mohammad Siddick |
source
presentation source |
7 |
| PHUSE EU |
2013 |
Designing ADaM Datasets: KISS the Complexity Goodbye [presentation] |
Bill J. Gibson |
source |
13 |
| PHUSE EU |
2013 |
Evolving Regulatory Guidance on the Submission of Standardised Data [presentation] |
James R. Johnson |
source |
25 |
| PHUSE EU |
2013 |
EXACT - A Metadata Driven System for Creating Standard Mockups and Data Displays [presentation] |
Kent Letourneau |
source |
55 |
| PHUSE EU |
2013 |
Interpreting CDISC ADaM IG Through Users Interpretation |
Angelo Tinazzi |
source
presentation source |
12 |
| PHUSE EU |
2013 |
Maintaining Consistency Between a Substance Database and Single Study Databases |
Dieter Hartz |
source
presentation source |
4 |
| PHUSE EU |
2013 |
Orphan Indication Therapies: Programming for a Patient Population without Options [presentation] |
Todd Case |
source |
24 |
| PHUSE EU |
2013 |
Report Inspector |
Vibhavari Inamdar |
source
presentation source |
11 |
| PHUSE EU |
2013 |
Standards for the Management of Clinical Trial Data, Why are they Needed, What is Needed? |
Isabelle Abousahl |
source
presentation source |
11 |
| PHUSE EU |
2013 |
The Missing Link: Results Level Metadata |
Jeffrey M. Abolafia |
source
presentation source |
9 |
| NESUG |
2013 |
The ADaM Solutions to Non-endpoints Analyses |
Chengxin Li |
|
12 |
| PharmaSUG |
2013 |
ADaM Datasets for Graphs |
Kevin Lee,
Chris Holland |
source |
15 |
| PharmaSUG |
2013 |
Building Traceability for End Points in Analysis Data Sets Using SRCDOM, SRCVAR, and SRCSEQ Triplet |
Xiangchen (Bob) Cui,
Tathabbai Pakalapati,
Qunming Dong |
source |
12 |
| PharmaSUG |
2013 |
Defensive Programming and Error-handling: The Path Less Travelled |
Tracy Sherman,
Angela S. Ringelberg |
source |
9 |
| PharmaSUG |
2013 |
Derived observations and associated variables in ADaM datasets |
Arun Raj Vidhyadharan |
source |
7 |
| PharmaSUG |
2013 |
Designing and Tuning ADaM Datasets |
Songhui Zhu |
source |
9 |
| PharmaSUG |
2013 |
From Standards that Cost To Standards that Save: Cost Effective Standards Implementation |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source |
9 |
| PharmaSUG |
2013 |
Hands-On ADaM ADAE Development |
Sandra Minjoe |
source |
7 |
| PharmaSUG |
2013 |
If 'standard code' is so great ... |
Brian P. Fairfield-Carter |
source |
12 |
| PharmaSUG |
2013 |
Introduction to the CDISC Standards |
Sandra Minjoe |
source |
10 |
| PharmaSUG |
2013 |
Just Press the Button: Generation of SAS Code to Create Analysis Datasets directly from an SAP - Can it be Done? |
Endri Endri,
Rowland Hale |
source |
8 |
| PharmaSUG |
2013 |
Macro %D_ADSL - Automating ADSL Creation from Metadata File |
Jian Hua (Daniel) Huang |
source |
9 |
| PharmaSUG |
2013 |
Traceability in the ADaM Standard |
Ed Lombardi |
source |
8 |
| SGF |
2013 |
A Preventive Approach for Automatic Checking of CDISC ADaM Metadata to Detect Noncompliance [presentation] |
Xiangchen (Bob) Cui,
Min Chen,
Tathabbai Pakalapati |
source |
2 |
| SGF |
2013 |
Adding New Rows in the ADaM Basic Data Structure: When and How |
Mario Widel,
Sandra Minjoe |
source |
12 |
| SGF |
2013 |
Building Traceability for End Points in Analysis Data Sets Using SRCDOM, SRCVAR, and SRCSEQ Triplet |
Qunming Dong,
Tathabbai Pakalapati,
Xiangchen (Bob) Cui |
source
pdf |
12 |
| SGF |
2013 |
From SDTM to ADaM |
Bob Lan,
Regan Li,
Sai Ma,
Suwen Li |
source
pdf |
7 |
| SGF |
2013 |
Knowing When To Start, Where You Are, and How Far You Need To Go: Customized Software Tracks Project Workflow, Deliverables, and Communication |
Eric Vandervort |
source |
14 |
| SGF |
2013 |
Using the ADaM ADAE Structure for Non-AE Data |
Mario Widel,
Sandra Minjoe |
source |
13 |
| SCSUG |
2012 |
Keep it Organized: A Grad Student "How To" Paper |
Elisa L. Priest |
source |
6 |
| SCSUG |
2012 |
POSTER: ADaM Implications of the CDER Data Standards Common Issues Document |
Sandra Minjoe |
source |
6 |
| PHUSE EU |
2012 |
ADaM in a Pool! A Concept on how to Create Integrated ADaM Datasets [poster] |
Alexandru Cuza |
source |
1 |
| PHUSE EU |
2012 |
ADaM Or SDTM? A Comparision of Pooling Strategies for Integrated Analyses in the Age of CDISC |
Joerg Guettner,
Alexandru Cuza |
source
presentation source |
7 |
| PHUSE EU |
2012 |
Approaches to Creating ADaM Subject-Level Analysis Datasets (ADSL) for Integrated Analyses |
Thomas Clinch,
Nate Friemark |
source
presentation source |
6 |
| PHUSE EU |
2012 |
Considerations for CSR Output Production from ADaM Datasets |
Andrew Noller |
source
presentation source |
1 |
| PHUSE EU |
2012 |
Cost Effective Standards Implementation: A New Paradigm for the Drug Development Life Cycle |
Jeff Abolafio,
Frank C. DiIorio |
source
presentation source |
9 |
| PHUSE EU |
2012 |
Enhancing Research Through Clinical Data Standardisation |
Pankaj Bhardwaj |
source
poster source |
1 |
| PHUSE EU |
2012 |
Interpreting ADaM Standards with OpenCDISC |
Trupti Bal,
Madhura Paranjape |
source
presentation source |
8 |
| PHUSE EU |
2012 |
Mapping the Company's Legacy Data Model to SDTM |
Anja Feuerbacher,
Bruce Rogers |
source
presentation source |
7 |
| PHUSE EU |
2012 |
Pooling Clinical Data: Key Points and Pitfalls |
Florence Buchheitt |
source
presentation source |
8 |
| PHUSE EU |
2012 |
SDTM and AdaM: Metadata Playing Together Nicely |
Kenneth Stoltzfus |
source
presentation source |
7 |
| PHUSE EU |
2012 |
The 3 Year Obsession: Length of Experiences the Sole Determinant of Competence? |
Meghana Bhagwat,
Manjusha Gode |
source
presentation source |
9 |
| PHUSE EU |
2012 |
Validation in Epidemiological Studies [presentation] |
Raimund Storb |
source |
24 |
| SESUG |
2012 |
Knowing When To Start, Where You Are, and How Far You Need To Go: Customized Software Tracks Project Workflow, Deliverables, and Communication |
Eric Vandervort |
source |
14 |
| WUSS |
2012 |
Developing Integrated Summary of Safety Database using CDISC Standards |
Rajkumar Sharma |
source |
7 |
| PharmaSUG CN |
2012 |
Methods to Generate Unavailable Categories in Interim Analysis |
Xiaoran Yin |
|
6 |
| PharmaSUG |
2012 |
"Analysis-ready" - Considerations, Implementations, and Real World Applications |
Ellen (Zihui) Lin,
Beiying Ding |
source |
6 |
| PharmaSUG |
2012 |
7 Steps to Progression Free Survival Insights Using SAS |
Karen Walker |
source |
12 |
| PharmaSUG |
2012 |
A Complex ADaM dataset? Three different ways to create one. |
Kevin Lee |
source |
11 |
| PharmaSUG |
2012 |
ADaM Implications from the "CDER Data Standards Common Issues" and SDTM Amendment 1 Documents |
Sandra Minjoe |
source |
6 |
| PharmaSUG |
2012 |
An Innovative ADaM Programming Tool for FDA Submission |
Xiangchen (Bob) Cui,
Min Chen,
Tathabbai Pakalapati |
source |
25 |
| PharmaSUG |
2012 |
Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission |
Xiangchen (Bob) Cui,
Min Chen |
source |
15 |
| PharmaSUG |
2012 |
Automatic Detection and Identification of Variables with All Missing Values in SDTM/ADaM Datasets for FDA Submission |
Min Chen,
Xiangchen (Bob) Cui |
source |
7 |
| PharmaSUG |
2012 |
Automatic Version Control and Track Changes of CDISC ADaM Specifications for FDA Submission |
Xiangchen (Bob) Cui,
Min Chen |
source |
8 |
| PharmaSUG |
2012 |
Building Flexible ADaM Analysis Variable Metadata |
Songhui Zhu,
Lin Yan |
source |
10 |
| PharmaSUG |
2012 |
CDISC ADaM Application: Does All One-Record-per-Subject Data Belong in ADSL? |
Sandra Minjoe |
source |
10 |
| PharmaSUG |
2012 |
Common Misunderstandings about ADaM Implementation |
Nate Freimark,
Susan J. Kenny,
Jack Shostak,
John K. Troxell |
source |
10 |
| PharmaSUG |
2012 |
Could Have, Would Have, Should Have! Adopting Good Programming Standards, Not Practices, to Survive An Audit. |
Vincent J. Amoruccio |
source |
17 |
| PharmaSUG |
2012 |
Creating an Integrated Summary of Safety Database using CDISC ADaM : Challenges, Tips and Things to Watch Out |
Rajkumar Sharma |
source |
7 |
| PharmaSUG |
2012 |
Creating the Time to Event ADaM Dataset: The Nuts and Bolts |
Nancy Brucken,
Paul K. Slagle |
source |
7 |
| PharmaSUG |
2012 |
Database Tectonics: Assessing Drift in Analysis Data |
Brian P. Fairfield-Carter,
Jasmin Fredette |
source |
10 |
| PharmaSUG |
2012 |
Identifying and Verifying Treatment-Emergent Adverse Events and Concomitant Medications by Date Specificity |
Tom Santopoli |
source |
5 |
| PharmaSUG |
2012 |
Metadata: Some Fundamental Truths |
Frank C. DiIorio |
source |
10 |
| PharmaSUG |
2012 |
Multiple Applications of ADaM Time-to-Event Datasets |
Huei-Ling Chen,
Helen Wang |
source |
6 |
| PharmaSUG |
2012 |
SDTM Domain Development on the Critical Path - Strategies for Success |
David C. Izard |
source |
5 |
| PharmaSUG |
2012 |
Streamlining Regulatory Submission with CDISC/ADaM Standards for Non-standard Pharmacokinetic/Pharmacodynamic Analysis Datasets |
Xiaopeng Li,
Katrina E. Canonizado,
Chun Feng,
Nancy Wang |
source |
6 |
| SGF |
2012 |
Automatic Consistency Checking of Controlled Terminology and Value Level Metadata between ADaM Datasets and Define.xml for FDA Submission |
Xiangchen (Bob) Cui,
Min Chen |
source |
15 |
| SGF |
2012 |
Examples of Building Traceability in CDISC ADaM Datasets for FDA Submission |
Xiangchen (Bob) Cui,
Hongyu Liu,
Tathabbai Pakalapati |
source |
14 |
| SGF |
2012 |
SAS Macros to Transpose SDTM Data Sets Automatically |
Chunmao Wang |
source |
7 |
| SGF |
2012 |
Using DDE and VBA Techniques to Import Data from Microsoft Word Tables in Programming Specification Files into SAS |
Mei Li,
Zemin Zeng |
source |
9 |
| SCSUG |
2011 |
Intro to Longitudinal Data: A Grad Student "How-To" Paper |
Elisa L. Priest |
source |
14 |
| SESUG |
2011 |
Development of a SAS Macro for Automated Data Cleaning of Major Outcomes of Interest in Hematopoietic Cell Transplantation |
Peigang Li,
Min Chen,
Zhiwei Wang |
source |
7 |
| SESUG |
2011 |
The Last Line |
Brandon Barrett,
Human Genome |
source |
5 |
| PHUSE EU |
2011 |
ADaM on a diet: preventing wide and heavy analysis datasets |
Dirk Van Krunckelsven |
source
presentation source |
5 |
| PHUSE EU |
2011 |
ADaM Validation and Integrity Checks |
Louise Cross |
source
presentation source |
5 |
| PHUSE EU |
2011 |
Creating ADaM Friendly Analysis Data from SDTM Using Meta Data |
Erik Brun,
Rico Schiller |
source
presentation source |
6 |
| PHUSE EU |
2011 |
Extension of the Six Steps Approach: How to go from an SDTM finding domain to an ADaM-compliant AD |
Carl Herremans,
Qian Wang |
source
poster source |
5 |
| PHUSE EU |
2011 |
Managing data issues identified during programming |
Shafi Chowdhury,
Aminual Islam |
source
presentation source |
5 |
| PHUSE EU |
2011 |
Modular Programming - Some Lessons Learned and Benefits Gained |
Ross Farrugia |
source
presentation source |
6 |
| PHUSE EU |
2011 |
Much ADaM about Nothing - a PROC Away in a Day |
Endri Endri,
Rowland Hale |
source
presentation source |
8 |
| PHUSE EU |
2011 |
Programming for Early and Late Phase - really that different? |
Katherine Macey |
source
presentation source |
6 |
| PHUSE EU |
2011 |
SDTM Domain QS: Challenges and Pitfalls - an Interpretation Guide to the Implementation Guide |
Knut Mueller |
source
presentation source |
6 |
| MWSUG |
2011 |
Tracking Metadata within SAS Drug Development Using SDDPARMS |
Bradford J. Danner,
Matthew J. Wiedel,
Katrina E. Canonizado |
|
7 |
| NESUG |
2011 |
Metadata: Some Fundamental Truths |
Frank C. DiIorio |
|
9 |
| NESUG |
2011 |
Product Repository: Oblectives and Utilization - A Case Study |
Amit Bhanose,
Smitha Mullapudi |
|
5 |
| PharmaSUG |
2011 |
ADaM Standard Naming Conventions are Good to Have |
Christine S Teng |
source |
8 |
| PharmaSUG |
2011 |
Automating the Process of Preparing Data Definition Document for NDA Electronic Submission from Programming Specification in Word Format |
Min Chen,
Xiangchen (Bob) Cui,
Scott E. Moseley |
source |
12 |
| PharmaSUG |
2011 |
Brave New World: How to Adapt to the CDISC Statistical Computing Environment |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source |
11 |
| PharmaSUG |
2011 |
Challenges in Implementing ADaM datasets: Balancing the Analysis-Ready and Traceability Concepts |
Pushpa Saranadasa |
source |
7 |
| PharmaSUG |
2011 |
Efficiencies Realized in Building and Utilizing ADaM from SDTM |
Shirish Nalavade,
Parag Shiralkar |
source |
5 |
| PharmaSUG |
2011 |
From SAP to BDS: The Nuts and Bolts |
Nancy Brucken,
Paul K. Slagle |
source |
9 |
| PharmaSUG |
2011 |
Making a List, Checking it Twice (Part 1): Techniques for Specifying and Validating Analysis Datasets |
Elizabeth Li,
Linda Collins |
source |
8 |
| PharmaSUG |
2011 |
Methods of Building Traceability for ADaM Data |
Songhui Zhu,
Lin Yan |
source |
9 |
| PharmaSUG |
2011 |
Producing Clinical Laboratory Shift Tables From ADaM Data |
Rao Bingi |
source |
12 |
| PharmaSUG |
2011 |
Tracking Metadata within SAS Drug Development Using SDDPARMS |
Bradford J. Danner,
Matthew J. Wiedel,
Katrina E. Canonizado |
source |
7 |
| PharmaSUG |
2011 |
Truncation, Variable Association, Controlled Terminology, and Some Other Pitfalls in the SDTM Mapping Process |
Na Li,
Gary de Jesus,
Daniel Bonzo |
source |
8 |
| PharmaSUG |
2011 |
Using the ADaM Basic Data Structure for Survival Analysis |
Nancy Brucken,
Sandra Minjoe,
Mario Widel |
source |
5 |
| NESUG |
2010 |
Date Conversions in SDTM and ADaM Datasets |
Lily Zhang,
Lili Chen,
Huei-Ling Chen |
|
8 |
| NESUG |
2010 |
Outsourced Data Integration Project with CDISC SDTM and ADaM Deliverables |
Margaret M. Coughlin,
Christine S Teng |
|
11 |
| NESUG |
2010 |
The 5 Biggest Challenges of ADaM |
Terek J. Peterson,
David C. Izard |
|
11 |
| NESUG |
2010 |
TRACKING DATASET DEPENDENCIES IN CLINICAL TRIALS REPORTING |
Binoy Varghese,
Satyanarayana Mogallapu |
|
10 |
| WUSS |
2010 |
Automation of 'makefile' for Use in Clinical Development |
Nalin Tikoo |
source |
7 |
| WUSS |
2010 |
Strategies for Building and Utilizing an Integrated Safety Database Using SAS |
Denise J. Smith |
source |
11 |
| PHUSE EU |
2010 |
A Case Study in Using Unit Testing as a Method of Primary Validation |
Ross Farrugia |
source
presentation source |
12 |
| PHUSE EU |
2010 |
Challenges of Clinical projects shared between Pharma Companies [presentation] |
Oliver LeConte |
source |
27 |
| PHUSE EU |
2010 |
Defining "Compliance" for Analysis Data |
Chris Decker,
Randall Austin |
source
presentation source |
7 |
| PHUSE EU |
2010 |
Generate ATTRIB and FORMAT statements from the SAP |
Shafi Chowdhury |
source
presentation source |
7 |
| PHUSE EU |
2010 |
How to clean up dirty data in Patient reported outcomes? |
Knut Mueller |
source
presentation source |
6 |
| PHUSE EU |
2010 |
How to go From an SDTM Findings Domain to an ADaM-Compliant Analysis Dataset: An Example |
Carl Herremans |
source
presentation source |
8 |
| PHUSE EU |
2010 |
Initial Investment in CDISC Data Standards in Clinical Organisations |
Kenneth Stolzfus |
source |
10 |
| PHUSE EU |
2010 |
The Ultimate Integration Challenge |
Jennifer Choon-Moi Chin,
Hester Schoeman |
source
presentation source |
11 |
| PHUSE EU |
2010 |
Traceability between SDTM and ADaM converted analysis datasets |
Florence Somers,
Michael Knoessl |
source
presentation source |
7 |
| PHUSE EU |
2010 |
Validation Strategies for Report Objects and Programs - Challenges and Obstacles in a Risk Based World |
Christoph Ziegler,
Beate Hientzsch |
source
presentation source |
12 |
| SESUG |
2010 |
A Taste of ADaM |
Beilei Xu |
source |
9 |
| PharmaSUG |
2010 |
ADaM Dataset Checking Toolkit |
Huei-Ling Chen |
|
9 |
| PharmaSUG |
2010 |
Applying ADaM Principles in Developing a Response Analysis Dataset |
Mei Dey,
Lisa Pyle |
|
8 |
| PharmaSUG |
2010 |
Automating the Link Between Metadata and Analysis Datasets |
Misha Rittmann |
|
5 |
| PharmaSUG |
2010 |
Building Effective Statistical Programming Teams for Clinical Trials |
Dawn Edgerton |
|
3 |
| PharmaSUG |
2010 |
Checking for SDTM Compliance: The Need for Human Involvement |
Fred Wood,
Adrienne Boyance |
|
8 |
| PharmaSUG |
2010 |
Considerations for Building an Integrated Safety Database Using SAS |
Denise J. Smith,
Daniel Schulz,
Gayle Kloss,
Wei Cheng |
|
10 |
| PharmaSUG |
2010 |
Don't run away, it's only Labs |
Lucy Wang,
Paul K. Slagle |
|
4 |
| PharmaSUG |
2010 |
From SAP to ADaM: The Nuts and Bolts |
Nancy Brucken,
Paul K. Slagle |
|
9 |
| PharmaSUG |
2010 |
Help! The EX Domain is Now an Analysis Dataset! What Do I Do?!? |
David C. Izard |
|
4 |
| PharmaSUG |
2010 |
How to build ADaM from SDTM: A real case study |
Jian Hua (Daniel) Huang |
|
12 |
| PharmaSUG |
2010 |
Insights into ADaM |
Matthew J. Becker |
|
9 |
| PharmaSUG |
2010 |
Looking for columns with all missing values |
Binoy Varghese |
|
5 |
| PharmaSUG |
2010 |
PROC CPM for Project Management 'Activity-On-Arc (AOA) or Activity-On-Edge (AOE)' Method |
Venkateshwaran Lajapathirajan |
|
8 |
| PharmaSUG |
2010 |
Sort Your Problems: Using SORTEDBY to Compare Datasets |
Sanket Kale |
|
5 |
| PharmaSUG |
2010 |
The 5 Biggest Challenges of ADaM |
Terek J. Peterson |
|
11 |
| PharmaSUG |
2010 |
The Manager's Skill Set: How to Move from Programmer to Manager |
Paul A. LaBrec |
|
7 |
| PharmaSUG |
2010 |
The SE Domain as Treatment Data Store: Using the SDTM Subject Elements (SE) domain to drive analyzing treatment |
Jeremy Gratt |
|
10 |
| SESUG |
2009 |
Building Effective Statistical Programming Teams for Clinical Trials |
Dawn Edgerton |
source |
4 |
| PHUSE EU |
2009 |
Acceleration through Collaboration |
Carrie Eason |
source
presentation source |
7 |
| PHUSE EU |
2009 |
Creating Articulate and Captivating e-Learning Courses |
Tony Cooper |
source |
7 |
| PHUSE EU |
2009 |
Implementation of ADaM standards NOT driven by a submission |
Karin Fleischer |
source
presentation source |
7 |
| PHUSE EU |
2009 |
Implementation of CDISC Standards at Nycomed [presentation] |
Berthold Traub |
source |
31 |
| PHUSE EU |
2009 |
Insights into ADaM |
Matthew J. Becker |
source
presentation source |
9 |
| NESUG |
2009 |
A Proposed SDTM Implementation of Response Data for Solid Tumor Trials in Oncology |
Mei Dey,
Elisabeth Pyle |
|
18 |
| NESUG |
2009 |
LOCF: It's more than just carrying forward |
Vikash Jain,
Niraj J. Pandya |
|
10 |
| NESUG |
2009 |
Successful Lab Result Conversion for LAB Analysis Data with Minimum Effort |
Pushpa Saranadasa |
|
8 |
| WUSS |
2009 |
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics |
Fred Wood |
source |
9 |
| PharmaSUG |
2009 |
A SAS Macro for Creating Adverse Event Analysis Dataset |
Daniel Li,
Suwen Li,
Stephanie Sproule |
|
10 |
| PharmaSUG |
2009 |
ARROW Clinical Data Analysis System: An Integration of Statistical Analysis and Reporting |
Cheng Jun Tian,
Denis Michel |
|
9 |
| PharmaSUG |
2009 |
Converting the define.xml to a Relational Database to Enable Printing and Validation [presentation] |
Lex Jansen |
|
76 |
| PharmaSUG |
2009 |
Creating the Case Report Tabulation (CRT) for an NDA submission at the absolute last moment - NOT |
Christine Connolly,
Kevin King,
Amanda Tweed,
Steven Wong |
|
9 |
| PharmaSUG |
2009 |
Data Conversion to SDTM: What Sponsors Can Do to Facilitate the Process |
Fred Wood |
|
6 |
| PharmaSUG |
2009 |
Implementation Plan for CDISC SDTM & ADaM Standards at MedImmune |
Alan Meier |
|
11 |
| PharmaSUG |
2009 |
Implementing CDISC When You Already Have Standards |
Sandra Minjoe |
|
10 |
| SGF |
2009 |
Backpacking Your Way through CDISC: A Budget-Minded Guide to Basic Concepts and Implementation |
Rachel Brown,
Jennifer K. Fulton |
source |
7 |
| SGF |
2009 |
Get Your Data Squeaky Clean with SAS Data Quality Server |
Faron Kincheloe |
source |
16 |
| SGF |
2009 |
Get Your Hands Dirty Cleaning Your Data with SAS Data Quality Server |
Faron Kincheloe |
source |
16 |
| SGF |
2009 |
Implementing CDISC When You Already Have Standards: A Case Study |
Sandra Minjoe |
source |
10 |
| PHUSE EU |
2008 |
CDISC Implementation Strategies: Exploit your data assets while still giving the FDA what they want |
David Smith |
source |
9 |
| PHUSE EU |
2008 |
CDISC: Implementation Strategies for SDTM |
Brian Mabe |
source |
5 |
| PHUSE EU |
2008 |
Implementing CDISC at Boehringer Ingelheim |
Michael Knoessl,
Peter Leister |
source |
5 |
| PHUSE EU |
2008 |
SHARE - A Reporting System for Efficacy Outputs using SAS Macro |
Vinod Kaippillil Mukundaprasad |
source |
9 |
| PNWSUG |
2008 |
Fast and Efficient Updates to Project Deliverables: The Unix/GNU Make Facility as a Cross-Platform Batch Controller for SAS |
Stephen Hunt |
|
12 |
| NESUG |
2008 |
Get Your Hands Dirty Cleaning Your Data with SAS Data Quality Server |
Faron Kincheloe |
|
17 |
| NESUG |
2008 |
Motivating Clinical SAS Programmers |
Daniel J. Boisvert,
Andy Illidge |
|
8 |
| PharmaSUG |
2008 |
Automated SAS Macro for Adverse Event Logistic Regression Analysis |
Suhas R. Sanjee |
|
8 |
| PharmaSUG |
2008 |
Automatic Creation of a Makefile for Clinical Trial |
Vikas Gaddu |
|
8 |
| PharmaSUG |
2008 |
Fast and Efficient Updates to Project Deliverables: The Unix/GNU Make Facility as a Cross-Platform Batch Controller for SAS |
Make Facility |
|
12 |
| PharmaSUG |
2008 |
Managing The Change And Growth Of A Metadata-Based System |
Jeffrey M. Abolafia,
Frank C. DiIorio |
|
11 |
| PharmaSUG |
2008 |
SDTM, Plus or Minus |
Barry R. Cohen |
|
6 |
| PharmaSUG |
2008 |
SHARE - A Reporting System for Efficacy Outputs using SAS Macro |
Axel Muehlig |
|
12 |
| PharmaSUG |
2008 |
Using Automated File Comparisons to Increase Efficiency and Accuracy in SAS Code Development & Validation |
Jasmin Fredette |
|
13 |
| SGF |
2008 |
Fast and Efficient Updates to Project Deliverables: The UNIX and GNU Make Facility as a Cross-Platform Batch Controller for SAS |
Brian P. Fairfield-Carter,
Stephen Hunt |
source |
12 |
| SGF |
2008 |
Get Your Hands Dirty Cleaning Your Data with SAS Data Quality Server |
Faron Kincheloe |
source |
17 |
| SGF |
2008 |
In Search for a Golden Algorithm |
Tamara S. Slipchenko,
Candice Bowman,
Catherine Sugar,
Allen L. Gifford |
source |
9 |
| SGF |
2008 |
Managing The Change And Growth Of A Metadata-Based System |
Jeffrey M. Abolafia,
Frank C. DiIorio |
source |
11 |
| SGF |
2008 |
Standard Management-Approved Report Templates: The SMART System |
Gary S. Stevens |
source |
7 |
| NESUG |
2007 |
Using SAS ODS to Extract and Merge Statistics from Multiple SAS Procedures into a Single Summary Report, a Detailed Methodology |
Stuart D. Long,
Jeffrey M. Abolafia,
Lawrence Park |
|
22 |
| WUSS |
2007 |
Case Study: Development of an HIV casefinding algorithm with SAS Enterprise Miner |
Tamara Slipchenko,
Candice Bowman,
Yuexin (Cindy) Chen,
Catherine Sugar,
Allen L. Gifford |
source |
9 |
| PHUSE EU |
2007 |
Check for SAS files consistency |
Arnaud Dauchy |
source |
29 |
| PHUSE EU |
2007 |
Electronic submissions - the role of the programmer |
Simon Dundas |
source |
8 |
| PHUSE EU |
2007 |
Standard Management Approved Report Templates |
Gary S. Stevens |
source |
7 |
| PHUSE EU |
2007 |
Standardization of submission data sets and analysis data sets |
Yvane Boudraa |
source |
4 |
| SCSUG |
2007 |
What Can DQ Do for You? |
Faron Kincheloe |
|
11 |
| PNWSUG |
2007 |
Mapping without GMAP: An Innovative Use of the SAS/GRAPH Annotate Facility [presentation] |
Peter J. Lund |
|
16 |
| PharmaSUG |
2007 |
An Efficient Report Checking Method |
Xuejing (Susan) Mao,
Mario Widel |
|
7 |
| PharmaSUG |
2007 |
Automatic Creation of Analysis Datasets for Clinical Trials - A Macro Program |
John H. Adams |
|
17 |
| PharmaSUG |
2007 |
Developing Reporting & Analysis Methodologies |
Amy Gillespie,
Mary N. Varughese |
|
5 |
| PharmaSUG |
2007 |
Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) |
Fred Wood,
Tom Guinter |
|
7 |
| PharmaSUG |
2007 |
From CRF Data to DEFINE.XML: Going "End to End" with Metadata |
Frank C. DiIorio,
Jeffrey M. Abolafia |
|
20 |
| PharmaSUG |
2007 |
Managing the CRO Relationship to Effectively Request and Receive CDISC STDM and ADaM Deliverables |
Kenneth Eng,
David C. Izard,
Terek J. Peterson |
|
8 |
| PharmaSUG |
2007 |
SDTM, Plus or Minus |
Barry R. Cohen |
|
6 |
| SGF |
2007 |
Gaining Power from GTL and ODS Style to Control Graphical Output |
Lea Guo,
Nan McCarthy,
William F. Liu |
source |
9 |
| SGF |
2007 |
The Electronic Project: Effectively Using Metadata throughout the Project Life Cycle |
Jeffrey M. DiIorio,
Frank Abolafia |
source |
18 |
| SCSUG |
2006 |
Data requests, quickly |
Elisa L. Priest |
|
6 |
| SCSUG |
2006 |
Keep it Organized - SAS tips for a research project |
Elisa L. Priest |
|
4 |
| PHUSE EU |
2006 |
Using CDISC Models for the Analysis of Safety Data |
Susan J. Kenny,
Edward D. Helton |
source |
10 |
| SESUG |
2006 |
Using SAS ODS to Extract and Merge Statistics from Multiple SAS Procedures into a Single Summary Report, a Detailed Methodology |
Stuart D. Long |
source |
21 |
| WUSS |
2006 |
Have It Both Ways: Macros that Produce Publication-Quality Tables and Stand-alone Code |
Linda Collins,
Lisa Kaye Brooks,
Michael Rea,
Alan Hopkins |
source |
19 |
| WUSS |
2006 |
New CDISC Training Initiative |
Dana Rafiee |
source |
2 |
| PharmaSUG |
2006 |
CDISC Submission and Compliance Training, The New Virtual Learning Methodology |
Dana Rafiee,
Michael C. Palmer |
|
2 |
| PharmaSUG |
2006 |
Evolution and Implementation of the CDISC Study Data Tabulation Model (SDTM) |
Tom Guinter,
Fred Wood |
|
6 |
| PharmaSUG |
2006 |
Get your SAS in gear - Automate the Production of Analysis Datasets |
Liz Taylor,
Chadds Ford |
|
10 |
| PharmaSUG |
2006 |
MDMAP - An innovative application utilized in the management of clinical trial metadata |
Gregory Ridge,
Neeru Bhardwaj |
|
9 |
| PharmaSUG |
2006 |
Update: CDISC Interchange Abstract Harmonizing CDISC Models - SDTM & ADaM |
Edward D. Helton,
Stephen J. Ruberg,
Cathy Barrows,
Musa Nsereko,
Greg Anglin |
|
3 |
| SUGI |
2006 |
Moving from Programmer to Statistician - A Statistical Mentoring Program |
Emily Anne James |
source |
3 |
| SUGI |
2006 |
Using SAS ODS to Extract and Merge Statistics from Multiple SAS Procedures |
Stuart D. Long,
Jeffrey M. Abolafia,
Lawrence Park |
source |
21 |
| SESUG |
2005 |
Automated Excel-lent Validation |
Janet E. Stuelpner |
source |
9 |
| PHUSE EU |
2005 |
An Introduction to CDISC - Available CDISC Standards and Models and How SAS Supports These |
Laurie Rose |
source |
43 |
| PHUSE EU |
2005 |
An Introduction to CDISC - What is CDISC and Why Standards? |
Laurie Rose,
Becky Kush |
source |
41 |
| PHUSE EU |
2005 |
Customer oriented CDISC implementation |
Edelbert Arnold,
Ulrike Plank |
source
poster source |
13 |
| PHUSE EU |
2005 |
Mapping Corporate Data Standards to the CDISC Model |
David Parker |
source |
7 |
| PHUSE EU |
2005 |
ODM & define.xml |
David Iberson-Hurst |
source |
58 |
| PHUSE EU |
2005 |
The Future of CDISC |
Becky Kush |
source |
50 |
| PHUSE EU |
2005 |
Understanding what 'make' can do for you |
David J. Garbutt |
source |
1 |
| NESUG |
2005 |
MDMAP - An innovative application utilized in the management of clinical trial metadata |
Gregory Ridge,
Neeru Bhardwaj |
|
9 |
| PharmaSUG |
2005 |
Automated Excel-lent Validation |
Janet E. Stuelpner |
|
9 |
| PharmaSUG |
2005 |
Implementation of the CDISC SDTM at the Duke Clinical Research Institute |
Jack Shostak |
|
12 |
| PharmaSUG |
2005 |
Programming and Data Differences Between Clinical Trials and Observational Studies |
Margaret M. Coughlin |
|
6 |
| PharmaSUG |
2005 |
Some Statistical Programming Considerations for e-Submission |
Hang Pang |
|
6 |
| PharmaSUG |
2005 |
Strategies for Implementing SDTM and ADaM Standards |
Susan J. Kenny,
Michael A. Litzsinger |
|
8 |
| PharmaSUG |
2005 |
Streamlining Processes: Reconciling Programming and Documentation |
James E. Witt |
|
11 |
| PharmaSUG |
2005 |
The Role of Analysis Datasets in Successful FDA Advisory Meetings |
Sandy Chang |
|
9 |
| PharmaSUG |
2005 |
To Macro or Not To Macro? |
Amy Gillespie,
Blue Bell |
|
8 |
| WUSS |
2004 |
Successful FDA Advisory Meetings by using Analysis Datasets |
Sandy Chang,
Steven Wong |
source |
10 |
| PharmaSUG |
2004 |
Automation of Patient Narratives Using SAS and Analysis Datasets |
David C. Izard |
|
6 |
| PharmaSUG |
2003 |
CDISC, ADaM, and TTE: What Are These Acronyms and How Can They Help Me with My Filing? |
Sandra Minjoe,
Judy Phelps |
|
4 |
| NESUG |
2002 |
Focusing on Our New Deliverables--CRT and Analysis Data Sets |
Phebe Joseph |
|
8 |
| SUGI |
2002 |
Regulatory Review of Animal Carcinogenicity Studies Using SAS/IntrNet |
Ted J. Guo,
Feng Zhou |
source |
4 |
| NESUG |
2001 |
Developing and Implementing Programming Standards Without Stifling Programmer Creativity |
Paul Doucette |
|
5 |
| NESUG |
2000 |
A SAS Data Dictionary for Achieving Analysis Dataset Compliance to FDA Guidance on Providing Submissions in Electronic Format |
Thomas Guinter |
|
4 |
| PharmaSUG |
1997 |
Statistical Programming Workflow Process Improvement at Fujisawa USA |
Jay Erdman,
Paul M. Gilbert |
|
4 |
| PNWSUG |
1996 |
Using SAS View to Enhance Software Quality, Improve Data Security and Reduce Data Replication |
Adam Hendricks |
|
27 |
| SEUGI |
1996 |
TREEDISC - a method for identifying household segments |
Sten Sture |
source |
11 |
| SUGI |
1989 |
A SAS/AF Software Application to Build Programs from Independent Modules |
Steven Light |
source |
3 |
| SEUGI |
1987 |
The PC SAS System in a Laboratory Environment |
Jan Ruud Hansen,
Tore Kaasen |
source |
7 |
| SUGI |
1983 |
Transferring and Processing a "Very Large "Data Set from a PDP 11/34 to an IBM 360/370 |
Keith E. Muller,
Kathleen J. Seiple |
source |
6 |
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