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csr

119 papers and 27 presentations; 142 titles.

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Conference × Year × Title × Authors Extras Pages
WUSS 2026 Automating Excel Table of Contents Generation from SAS -Produced RTF Reports Without Predefined Metadata Joshua Lin source 9
PharmaSUG CN 2026 Exploring the Architecture of Statistical Programming Languages in the AI Era Jiang Chao,
Wang Li,
Wang Juan,
Su Ya,
Yan Na		 source 8
PHUSE US 2026 Bridging Analysis and Strategy: The Transformative Role of Statistical Analysts in Drug Development Lingsong Yun source
presentation source		 17
PHUSE US 2026 Changing rules on Data Ownership and Data Access [presentation] Darshan Kulkarni source 38
PHUSE US 2026 Enhancing Clinical Study Report Authoring with Generative AI: Lessons Learned on TFL Formatting and Metadata Integration in Merck's iRAP Tool Elisabeth Pyle,
Madhusudhan Reddy Papasani		 source
presentation source		 4
PHUSE US 2026 Implementing AI in Authoring Plain Language Summaries: Insights from a Live Project Experience [presentation] Vidhi Vashisht source 18
PHUSE US 2026 Opening Session - Global Data Sharing Platforms: Aligning Frameworks, Pressures and Opportunities [presentation] Cathal Gallagher source 31
PHUSE US 2026 Validating AI in GxP: Test Harnesses, Guardrails and Compliance Controls Bill Qubeck source
presentation source		 14
PHUSE US 2026 {tflmetaR}: An R Package to Manage Metadata of Statistical Outputs Gary Cao source
presentation source		 6
PHUSE APAC 2026 From Static to Interactive: A Comparative Evaluation of ggplot2 and Plotly in Clinical Data Visualisation Mugdha Joshi source
presentation source		 8
PHUSE EU 2025 Hybrid Way To Develop Patient Narratives [presentation] Loskutov Volodymyr,
Oleh Buno		 source 16
PHUSE EU 2025 Milestones Matter: Understanding Key Milestones in Clinical Trials Satyapal Gudla source
poster source		 21
PHUSE EU 2025 Turning Data into Deliverables: Automating Biometrics from Metadata to TFLs Inderjeet Arora source
presentation source		 9
WUSS 2025 Automating Clinical Study Reports: A Modular Framework for Continuous Data Reporting William Wei source 7
WUSS 2025 Reach for R Low Hanging Fruit for Faster Results Sunil Kumar Gupta source 4
PharmaSUG 2025 Catch Page Overflow Issues Quick and Easy - A Simple Python Solution Junze Zhang,
Huei-Ling Chen		 source 6
PharmaSUG 2025 Reach for R Low Hanging Fruit for Faster Results Sunil Kumar Gupta 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 Generate Clinical Study Reports (CSRs) Using {quarto} and {shiny} Peng Zhang,
Jimmy Chen		 source
presentation source		 9
PHUSE US 2025 Harnessing Analysis Results Datasets (ARDs) for Clinical Reporting in R: Our First ARD-Based Filing Experience Daniel Sjoberg,
Nolan Steed		 source 6
PHUSE US 2025 LLMs in Drug Development - The Future is Closer Than We Think Chris McSpiritt source
presentation source		 9
PHUSE US 2025 Topline Considerations for Double-Blind Trials Veena Palle,
Naresh Gopalkrishna		 source
poster source		 5
PHUSE EU 2024 Advances in Clinical Table Creation - Python Updates Philip Bowsher,
Michael Chow		 source
presentation source		 12
PHUSE EU 2024 Interactive Session - The State of Open Source Technology in Clinical Data Analysis, Reporting, and Submissions - A PHUSE Manuscript [presentation] Katja Glass,
Michael S Rimler		 source 27
PHUSE EU 2024 Navigate Clinical Study Report Tables and Listings - The iTable & iListing Project Katja Glass source
presentation source		 13
PHUSE EU 2024 SCE Alchemy: The Return of the QC Process, and Rise of Training via LLM Steve Griffiths,
Eleanor Sparling		 source
presentation source		 6
PHUSE EU 2024 Transcriptomics - A Demanding Data Analysis that Expands the Limits of Regulated Clinical Data Handling Lea Yoshida Hildebrandt source
presentation source		 6
PHUSE EU 2024 {r}amnog: Towards a Common, Open-Source Solution for Programming AMNOG-Style EU-HTA Analyses Matthew Phelps,
Christian Olsen		 source
presentation source		 6
PharmaSUG 2024 Go Get 'Em: Manager's Guide to Make a Winning Business Proposal for Technology Solutions Dilip Raghunathan source 7
PharmaSUG 2024 Semi-Automated and Modularized Approach to Generate Tables for Clinical Study - Categorical Data Report William Wei,
Shunbing Zhao		 source 8
PHUSE US 2024 Constructing Multilingual Visualisation Toolsets for Clinical Study Reports and Submission Jane X. Liao,
Bingjun Wang		 source
presentation source		 13
PHUSE US 2024 Digital Protocol Vision ... How Digital Information Can Transform and Automate Our Processes [presentation] Bill Qubeck,
Chris Decker		 source 27
PHUSE US 2024 Graphical overview for understanding, planning and execution of statistical programming activities using Neo4j Madhusudhan Reddy Mule Venkata source
presentation source		 13
PHUSE US 2024 NEST: How Could We Generate and Deliver Clinical Insights Even Faster? Vincent Shen source
presentation source		 4
PHUSE US 2024 The State of Open-Source Technology in Clinical Data Analysis, Reporting and Submissions - A PHUSE Manuscript Michael S Rimler source
presentation source		 1
PHUSE EU 2023 Challenges in Oncology Modular studies: The Fortrea approach Francesca Dall'Acqua source
presentation source		 7
PHUSE EU 2023 Connecting the Dots to Shape Our Future. The Exciting Journey of an Evolving Statistical Programming Team Alberto Montironi source
presentation source		 4
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 Same Same but Different: Leveraging R for Comparing Clinical Study TLF Versions source
presentation source		 3
PHUSE US 2023 A Beginner's Roadmap to Map Functions for Clinical Reporting in R Samuel Curlee,
Gabriela Piasecki		 source
presentation source		 6
PHUSE US 2023 Helping You Get in the Lightning Lane for a Wild Submissions Ride! [presentation] Ali Dootson source
video		 20
PHUSE EU 2022 Deep Learning to Classify Adverse Events from Patient Narratives [presentation] Qais Hatim,
Tom Sabo		 source
video		 12
PHUSE EU 2022 Harnessing AIML Technologies to Expedite Anonymisation of Unstructured Data: Implications for the EU CTR Niamh McGuinness,
Muhammad Oneeb Rehman Mian		 source
presentation source		 4
PHUSE EU 2022 Using Python to Compile CSR Loskutov Volodymyr source
video
presentation source		 4
PharmaSUG 2022 Just Say No to Data Listings! Mercidita Navarro,
Nancy Brucken,
Aiming Yang,
Greg Ball		 source 4
PharmaSUG 2022 Quality Gates: An Overview from Clinical SAS Programming Perspective Nagadip Rao,
Pavan Jupelli		 source 10
PHUSE US 2022 Practical Challenges in Handling Unstructured Data Using Artificial Intelligence [presentation] Farha Feroze source
video		 11
PHUSE US 2022 Statistical Programming Operational Review Dashboard [presentation] Kathleen J. Harkins,
Shuqi Zhao		 source
video		 16
PHUSE US 2022 The Emerging Use of Automation to Address the Challenge of Cross-Table Consistency Checking of Output Used in the Reporting of Clinical Trial Data [presentation] Hugh Donovan,
Naama Feilchenfeld		 source
video		 16
PHUSE US 2022 Title: AI Application for Authoring Clinical Study Reports [presentation] Eric Weising,
Farha Feroze		 source
video		 9
PHUSE EU 2021 Redefining Clinical Data Flow at AstraZeneca [poster] Malgorzata (Gosia) Grabowska source
video		 1
PHUSE US 2021 Automate Scientific Document such as CSR Generation using ML/NLP [presentation] Farha Feroze source
video		 13
PHUSE US 2021 FDA Conformance Analysis and Upcoming Implementation of Technical Rejection Criteria for Study Data [presentation] Ethan Chen,
Heather Crandall		 source 36
PHUSE US 2021 Good Cooperation Between SAS and R for Regulatory Submission [presentation] Jingyuan Chen source
video		 19
PHUSE US 2021 SimSCE: Building an SCE City to Support My Process [presentation] Andrew B. Ratcliffe,
Chris Decker		 source
video		 36
PHUSE US 2021 Standing Room Only Presentation: CM03: Quality Tolerance Limits: Leveraging Predictive Modeling [presentation] Christina Dinger,
Slade McKee		 source 18
PHUSE US 2021 Using Computer Vision to Identify and Extract Tables from Various File Formats [presentation] Kanishk Mair,
Shashank Pagidimarri		 source
video		 22
PHUSE US 2021 Visually-enhanced Patient Narrative [poster] Abhinav Srivastva source 1
PharmaSUG 2021 Agile Project Management in Analysis and Reporting of Late Stage Clinical Trial Sarad Nepal,
Uday Preetham Palukuru,
Peikun Wu,
Madhusudhan Ginnaram,
Ruchitbhai Patel,
Abhilash Chimbirithy		 source 11
PharmaSUG 2021 Application to Automate Clinical Study Report Generation using AI Farha Feroze source 5
PharmaSUG 2021 Automated CONSORT Flow Diagram Generation by SAS Programming Ryan Yu source 10
PharmaSUG 2021 PROC FUTURE PROOF v1.1 - Linked Data Amy Gillespie,
Susan Kramlik,
Suhas R. Sanjee,
Jindřich Mynarz,
Danfeng Fu		 source 12
SGF 2021 Deep Learning to Classify Adverse Events from Patient Narratives [presentation] Qais Hatim,
Tom Sabo		 source 19
PHUSE EU 2020 Application to Automate CSR Generation Using ML/NLP [presentation] Eric Weising,
Farha Feroze		 source
video		 10
PHUSE EU 2020 Managing an International Statistical Programming Team in the Era of New Ways of Working Frédéric Coppin,
Harris Kampouris		 source
video
presentation source		 8
SESUG 2020 Upgrading Clinical Trial Reports from ODS LISTING to ODS TAGSETS.RTF Christopher J. Smith source 25
SGF 2020 Metrics and Medical Writing - We Don't Just Count Words Daniel Augusto Muriel Ramirez,
Dominic De Bellis		 source 12
SGF 2020 Upgrading Clinical Trial Reports from ODS LISTING to ODS TAGSETS.RTF Christopher J. Smith,
Joshua M. Horstman		 source 25
PHUSE US 2020 A Programmer's Journey through the BIMO Submission Process Raghavender Ranga source
presentation source		 12
PHUSE US 2020 Regulatory Report Automation with R Shimeng Huang,
Suwen Li		 source
presentation source		 5
PHUSE US 2020 SmartLog - A UNIX based Utility Satish Honrao source
presentation source		 5
PHUSE EU 2019 Development of standard BIMO process to create clinsite dataset Hilde Delanghe source
presentation source		 8
PharmaSUG 2019 Automate the Process to Ensure the Compliance with FDA Business Rules in SDTM Programming for FDA Submission Xiangchen (Bob) Cui,
Hao Guan,
Min Chen,
Letan (Cleo) Lin		 source 16
PharmaSUG 2019 Camouflage your Clinical Trial with Machine Learning and AI Ajith Baby Sadasivan,
Limna Salim,
Akhil Vijayan,
Anoop Ambika		 source 10
PharmaSUG 2019 Clinical Development Standards for FDA Bioresearch Monitoring (BIMO) Submissions Denis Michel,
Julie Maynard		 source 11
PharmaSUG 2019 Large-scale TFL Automation for regulated Pharmaceutical trials using CDISC Analysis Results Metatadata (ARM) Stuart Malcolm source 16
PharmaSUG 2019 Sponsor Considerations for Building a Reviewer's Guide to Facilitate BIMO (Bioresearch Monitoring) Review Kiran Kumar Kundarapu,
Janet Low,
Majdoub Haloui		 source 5
PHUSE US 2019 Digital Analysis Results - #killTFLs Chris Decker source
presentation source		 6
PHUSE EU 2018 Text as Data in the Context of Anonymising Clinical Study Reports Lukas Kniola,
Tim Perin		 source
presentation source		 12
PHUSE US 2018 Convert the Clinical SAS datasets from RTF files [presentation] Murali Neela source 10
PHUSE US 2018 Cue the Word - QC - All You Need to Know! Subha Jamburajan,
Nancy Haeusser		 source
presentation source		 6
PharmaSUG 2018 Easy CSR In-Text Table Automation, Oh My Janet E. Stuelpner source 6
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
PHUSE EU 2017 Anonymisation of Clinical Study Reports Julie De Wever,
Marie-Anne Thil		 source
presentation source		 6
PHUSE EU 2017 EMA Policy 0070: Data Utility in Anonymized Clinical Study Reports (CSRs) Jean-Marc Ferran,
Sarah Nevitt		 source 23
PHUSE EU 2017 Visualizing Multiple Endpoints: Extending the Use of Forest Plots in Clinical Trials James R. Johnson,
Mark Jaros		 source
presentation source		 10
PharmaSUG 2017 Creating Define-XML version 2 including Analysis Results Metadata with the SAS Clinical Standards Toolkit Lex Jansen source 31
PharmaSUG 2017 Special Symbols in Graphs: Multiple Solutions Abhinav Srivastva source 12
PHUSE EU 2016 Standard Safety Visualisation Set-up Using Spotfire Michaela Mertes source
presentation source		 10
PharmaSUG 2016 Creating Define-XML version 2 including Analysis Results Metadata with the SAS Clinical Standards Toolkit Lex Jansen source 29
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
SGF 2016 Careers in Biotatistics and Clinical SAS Programming: An Overview for the Uninitiated Justina M. Flavin source 5
PHUSE EU 2015 'Dude. Where's My Graph?' RDF Data Cubes for Clinical Trial Data Tim P. Williams,
Marc Andersen		 source
presentation source		 7
PHUSE EU 2015 Constructing a Simple Data Repository [presentation] Magnus Mengelbier source 19
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
PHUSE EU 2014 Data Transparency: Moving from Bad Pharma to Good Science [presentation] Gary Hearfield,
Katherine Tucker		 source 1
WUSS 2014 Careers in Biostatistics and Clinical SAS Programming: An Overview for the Uninitiated Justina M. Flavin source 5
PharmaSUG 2014 Careers in Biostatistics and Clinical SAS Programming: An Overview for the Uninitiated Justina M. Flavin source 5
PharmaSUG 2014 Clinical Study Report Review: Statistician's Approach Amita Dalvi source 6
PharmaSUG 2014 Kaizen Usha Kumar source 5
PharmaSUG 2013 Efficient Statistical Review Using the ExcelXP Tagset Bradford J. Danner source 5
PHUSE EU 2012 "Bertha.sas" - User Friendly Ways to get Traceability Elena Glathe source
presentation source		 28
SESUG 2012 Developing a Complete Picture of Patient Safety in Clinical Trials Richard C. Zink,
Russell D. Wolfinger		 source 5
PharmaSUG CN 2012 Rising to Excellence - How a China CRO Achieves International Standards [presentation] Helen Yin,
Minzhi Liu		 27
PharmaSUG 2012 Giving Data a Voice: Partnering with Medical Writing for Best Reporting Practices Katherine Troyer,
Brit Minor		 source 8
PharmaSUG 2012 SDTM Domain Development on the Critical Path - Strategies for Success David C. Izard source 5
SGF 2012 Using the SAS ODS Report Writing Interface to Create Clinical Study Reports Rui Duan source 11
NESUG 2011 PROC REPORT: Various Reporting Layouts in Clinical Study Reports and Advance Techniques Santosh Bari 6
PharmaSUG 2011 A Non-Invasive Macro to Track Submission Metadata in SAS Drug Development Katrina E. Canonizado,
Bradford J. Danner,
Matthew J. Wiedel		 source 8
PharmaSUG 2011 New Tips and Tricks for Creating a Harmonized, Report-Friendly SDTM and ADaM Lab Data for a Clinical Study Report Xiangchen (Bob) Cui,
Min Chen,
Scott E. Moseley		 source 12
SGF 2011 A Non-Invasive Macro to Track Submission Metadata in SAS Drug Development Katrina E. Canonizado,
Bradford J. Danner,
Matthew J. Wiedel		 source 8
PHUSE EU 2010 AstraZENeca and the ART of metadata maintenance Paul Frost source
presentation source		 11
PHUSE EU 2010 GSTARS a complete strategy for the reporting [presentation] Alain Vasseur source 30
PHUSE EU 2010 Statistical Graphics for Review and Reporting in Clinical Development Kerstin Pietzko,
Michael O'Connell		 source
poster source		 12
PharmaSUG 2010 Accessing the metadata from the define.xml using XSLT transformations Lex Jansen 70
PharmaSUG 2010 Lessons Learned as a SAS Programming Lead Across Cultures Eunice Ndungu 5
PharmaSUG 2010 The CDISC/FDA Integrated Data Pilot: A Final Summary of Findings, Reviewer Feedback, and Recommendations Implementing CDISC Standards Within and Across Studies Chris Decker 20
PHUSE EU 2009 ClinicalTrials.gov - a programmers perspective Ralf Minkenberg source
presentation source		 6
PHUSE EU 2009 Medical Data Review in Exploratory Drug Development Michaela Jahn,
Joshua Haznedar		 source
presentation source		 21
PHUSE EU 2009 The CDISC/FDA Integrated Data Pilot: A Case Study in Implementing CDISC Standards to support an Integrated Review Chris Decker source
presentation source		 15
PharmaSUG 2009 ARROW Clinical Data Analysis System: An Integration of Statistical Analysis and Reporting Cheng Jun Tian,
Denis Michel		 9
PharmaSUG 2009 Automate the Process of Creating and Updating Titles and Footnotes of TLG for a Clinical Study Report from a Table Shell Document Xiangchen (Bob) Cui,
Shan Chen,
Mei Wu		 18
PHUSE EU 2008 Exchange of Information for the Statistical Analysis and Reporting of PK Parameter Data Ann Cuijpers,
Sarah Rusch		 source 2
PharmaSUG 2008 %YAMGAST: Yet Another Macro to Generate a Summary Table Zang Xiong,
St. Jude Children's		 10
PharmaSUG 2008 EZTABLE Macros Daniel Huang 12
PHUSE EU 2007 LSLV to Final CSR Tables in 24 hours - Dream or Reality? Stinder Fowler source 10
PHUSE EU 2007 MAKS: A validated SAS Macro Library for data in SDTM structure Rolf Meinert,
Katrin Bhalla-Muller		 source 3
PharmaSUG 2007 An Application of ODS Tagset to Produce HTML Files for Clinical Study Reports Li Luo 10
PHUSE EU 2006 Statistical Graphics and Reporting in Drug Development Michael O'Connell,
Sven Knudsen		 source 13
NESUG 2006 Tips and Traps in Large Scale Clinical Trials Changhong Shi 4
PharmaSUG 2006 Preparing CTD (Common Technical Document) for FDA Submission Charlie Xu 7
SUGI 2006 Moving from Programmer to Statistician - A Statistical Mentoring Program Emily Anne James source 3
PharmaSUG 2005 Constructing Stack Tables With Proc Report and ODS RTF Lei Zhang 11
PharmaSUG 2005 Extending the SAS Environment with Trellis Graphics Chris Thornton 7
PharmaSUG 2004 Automation of Patient Narratives Using SAS and Analysis Datasets David C. Izard 6
SUGI 2004 Two Approaches to the Summarization of Data Huijuan Xu,
John Hotaling		 source 5
NESUG 2003 Date/Time Stamped Files and Audit Trails: What Part 11 Compliant SAS Systems are Made Of Carolyn Dougherty 11
PharmaSUG 2003 Coordinated Efforts for Preparing Statistical Review Aids Coordinated Efforts 6
NESUG 2002 Efficiency and Quality Control in the Preparation of a Preparing Statistical Review Aid in FDA e-Submissions James Wu,
Frederick A. Cieri,
Amy Gillespie		 4
PharmaSUG 2002 IND Annual Reporting at a Glance Kristi Wiser 6
PharmaSUG 2002 Let ODS in SAS V8 Help to Speed Up Your Electronic Clinical Study Report (e-CSR) Jim J. Wang,
Sherry L. Pinnell,
Tikiri B. Karunasundera		 4
PharmaSUG 2002 Pitfalls and Successes of Automating In-Text Tables for a Clinical Study Report: A Case Study Matthew J. Becker 6
PharmaSUG 2001 Electronic Clinical Study Reports (e-CSR) using ODS in SAS V8e Hiroshi Otsu,
Tadayuki Kitagawa		 4
PharmaSUG 2001 From SAS ASCII Output to Word Document - A SAS Macro Approach Jianlin (Jay) Zhou 4
SUGI 2000 SAS Software and Microsoft Visual Basic for Applications Make Beautiful Reports Together Aileen L. Yam source 5
NESUG 1995 A Simple Methodology for Developing Clinical Reporting Macros Paul M. Gilbert,
Steven Light		 6

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