HOME QUICK SEARCH AUTHORS KEYWORDS HELP BUGS

regulatory submission

237 papers and 27 presentations; 260 titles.

Back to keywords

Conference × Year × Title × Authors Extras Pages
WUSS 2026 Smarter CRF Reviews: An Open-Source AI Tool for Automated Protocol-to-CRF Gap Analysis in Clinical Trials Raj Sharma source 9
WUSS 2026 Your PROCs Meet AI: Fuzzy vs. Semantic Matching in SLC Yulia Horwath source 31
PharmaSUG CN 2026 AI in Regulatory Submissions: Health Authority Expectations and Emerging Opportunities for Data Standards and Submission He Liu source 7
PharmaSUG CN 2026 Applying AI LLM to Reduce Manual Translation Workload in E-Data Package Submission Megan Chen source 7
PharmaSUG CN 2026 R Submissions in Practice: The J&J Implementation and Emerging AI Opportunities Wenlan Pan source 11
PharmaSUG 2026 A Practical Roadmap for Modernizing Legacy Clinical Applications David L. Ward source 15
PharmaSUG 2026 Accelerating CDISC SEND Conversion with AI: From Raw Preclinical Data to Regulatory-Ready Datasets Nattawit Pewngam,
Chotika Chatgasem,
Titipat Achakulvisut		 source 10
PharmaSUG 2026 An Alternative Option to Create XPT Files with a SAS Function Jose Hernandez Rivero,
Ruth Marisol Rivera Barragan		 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 Beyond Today-s Evidence: How AI-Enabled RWE Will Transform Development Speed, Study Quality, and Real-World Impact Sherrine Eid source 15
PharmaSUG 2026 DefinePageChecker: A Python Tool for Verifying Page Number Hyperlinks in Define.xml Xianhua Zeng source 4
PharmaSUG 2026 Early Unblinding to Pharmacometrics (PMx) Data: Challenges, Practices, and Benefits Shweta Vadhavkar,
Jing Su		 source 6
PharmaSUG 2026 Efficiency in Action: Automating Bookmarking for CRFs and Other Regulatory Submission Documents Srivathsa Ravikiran,
Sri Raghunadh Kakani,
Yang Xu		 source 11
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 From Automation to Evidence: Governing LLMs and AI Agents in Real-World Outcomes Research Sherrine Eid source 17
PharmaSUG 2026 From Chaos to Clarity: A Programmer-s Perspective on Standardizing Population Pharmacokinetic (PopPK) Data for Regulatory Success Naveen Muppalla,
Shibani Harite		 source 7
PharmaSUG 2026 From Manual to Automated": An SAS and R-Based Toolkit for Scalable SDTM Generation Hardik Sheth,
Eldho Alias		 source 8
PharmaSUG 2026 Investigator-Initiated Trials: Navigating Statistical Programming Challenges with Practical Solutions Vikas Patil,
Ramesh Sundaram		 source 6
PharmaSUG 2026 Keynote Presentation: Between Hype and Reality: Posit's Blueprint for Responsible GenAI in Life Sciences [presentation] Tareef Kawaf source 28
PharmaSUG 2026 Navigating Early Career Challenges in PK/ADA Statistical Programming Diyu Yang,
Sandeep Meesala		 source 11
PharmaSUG 2026 One Study, Many Regulators: Submission-Ready Data Package for Multi-Region Filings Himanshu Patel,
Chintan Pandya		 source 10
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 Schema-Preserving Generation of Clinical TLF Templates and Executable R Code via Iterative LLM-Guided Debugging Jaime Yan,
Ming Yang		 source 18
PharmaSUG 2026 Smarter, Faster, Better: GenAI-Driven Authoring for Data Reviewer's Guides Christina Scienski,
Christine Rossin		 source 4
PHUSE US 2026 Accelerating Study Insights: Agile Data Visualisation Using R-Shiny Lin Yuan,
Heather Howell		 source
presentation source		 6
PHUSE US 2026 Acquiring a Compound with Multiple Clinical Trials? Let's Get Ready for a Type C Meeting! Key Considerations for Preparing Its Regulatory Submission Mathura P. Ramanathan,
Kajal Tahiliani		 source
presentation source		 12
PHUSE US 2026 Advancing Transparency-by-Design in Clinical Trial Disclosure: Real-World Applications for Regulatory Submissions [presentation] Obaraboye Olude,
Chantal Din-Bell		 source 60
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 Breaking into Statistical Programming: How SAS, R, Python, AI and ML Are Shaping Career Paths Kishore Pothuri source
presentation source		 6
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 Building High-Quality SDTM from Real-World Data: Lessons and Solutions Peishan(Jenny) Han,
Lixiao Chen		 source
presentation source		 4
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 Deceptive Twins: An Interactive Python Tool for Automated RTF Document Comparison in Clinical Submissions Aravind Gajula source
presentation source		 8
PHUSE US 2026 Developing the Workforce of the Future Avinash Pati source
presentation source		 5
PHUSE US 2026 Digital Twins for Clinical Submissions: Simulating Regulatory Review Before Submission Heather Gorr,
Divya Kapoor		 source
presentation source		 9
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 Enhancing Clinical Trial Dataset Mapping with AI/ML Techniques: An Approach for CDISC Variable Prediction Parvee Kumar source
presentation source		 7
PHUSE US 2026 From Automation to Audit-Readiness-AI's Growing Role in Statistical Programming Manoj Kumar Maripally source
presentation source		 4
PHUSE US 2026 Interactive and Instant: GenAI-Driven Creation of Clinical Trial Applications Marcin Dubel source
presentation source		 12
PHUSE US 2026 Multi-Standard Submission - Process, Learnings and Recommendations for Best Practice Mukesh Garg source
presentation source		 8
PHUSE US 2026 Objects in Mirror Are Closer Than They Appear - How an Organisation Came Together to Accelerate Open Source Adoption Eileen Ching,
Benjamin Arancibia		 source
presentation source		 5
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 The Year of Yes! How saying "Yes" Ignited GSK's R Adoption Becca Krouse,
Benjamin Arancibia		 source
presentation source		 5
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 What Pharma Can Learn from Data Science Outside the Industry Kris Wenzel,
Liz Cole		 source
presentation source		 11
PHUSE APAC 2026 Accelerating Regulatory Submissions with R: A Scalable and Compliant Approach Priyanka Sawant source
presentation source		 6
PHUSE APAC 2026 An AI-Powered Digital Standards Library for Accelerated Regulatory Submissions Anshu Aman,
Varun Sethuraman		 source
presentation source		 4
PHUSE APAC 2026 Automation and Macros in Clinical Submissions: Challenges, Limits and the Path Forward Bharath Kumar Malipeddi source
presentation source		 3
PHUSE APAC 2026 Bridging the Divide: Harmonizing HL7 FHIR, OMOP, and CDISC Standards for Regulatory-Grade Real-World Evidence Yasa Sreekanth Reddy source
presentation source		 9
PHUSE APAC 2026 Building a Trustworthy RWD Analytics Platform Key Considerations and Strategies William Yuanhao Kuan,
Ashwini Reddy		 source
presentation source		 7
PHUSE APAC 2026 Charting New Territory: R-Based Submissions Made Easy Veena Terekar source
presentation source		 7
PHUSE APAC 2026 Creating a clinical trial data package for Regulatory submission Pradip Sivaramakrishnan,
Anbarasan Durairajan		 source
poster source		 11
PHUSE APAC 2026 Development of Statistical Scientists for Pharmaceutical Drug Development at India Global Capability Centres Suresh Chenji source
presentation source		 6
PHUSE APAC 2026 eDataValidator (eDV): Validating Clinical Data for Confident Submissions Pratika Chatterjee source
poster source		 4
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 From Clicks to Compliance: How eCRF Design Decisions Echo Through to Submission Mary Shefoli source
poster source		 2
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 APAC 2026 From XPT to JSON for submissions: Are we ready for the change? Poorna Suresh,
Bill Qubeck		 source
presentation source		 20
PHUSE APAC 2026 Innovating Clinical Signal Surveillance: Real-Time Dashboards for Protocol and PK Deviation Monitoring Rubina Pathan,
Jinu J. Nair		 source
poster source		 7
PHUSE APAC 2026 Key Programmer Tasks for Japan Submission and Programmer Role Allocation Yoko Yamaguchi source
presentation source		 5
PHUSE APAC 2026 Next-Gen Transport Standards: Dataset-JSON from a Programmer's Lens Venkata Koteswara Rao Rayala source
presentation source		 6
PHUSE APAC 2026 RADAR: Rapid AGILE Development and Automated Reporting for Clinical Data Standards (Using R Shiny based Application) Neeraj Sharma,
Dhirendra Kumar		 source
presentation source		 5
PHUSE APAC 2026 Summary Outputs Made Simple: A Mirror View for SAS Programmers Exploring R Venkata Koteswara Rao Rayala source
poster source		 7
PHUSE APAC 2026 The Expanding Role of Real-World Evidence (RWE) in Supporting Regulatory Submissions Setu Sagar,
Nikhil A		 source
presentation source		 6
PHUSE APAC 2026 TLF Treasure Hunt: Making Legacy Data Instantly Discoverable with RAD Finder Alexis Bernard Dalam,
Cielo Marie Castañeda		 source
presentation source		 6
PHUSE APAC 2026 Unlock Deeper Clinical Insights: A Unified Approach to Data Analysis with SAS, R, and Python Pavan Kallurkar source
presentation source		 7
PHUSE APAC 2026 Unveiling Powerful Patient Data Insights Through Graph Database Sonal Dedhia source
presentation source		 10
PHUSE EU 2025 Automating RTF-to-PDF Conversion for BIMO Submissions: A Python-Based End-to-End Solution [presentation] Yi Yan,
Po-Chun Lin		 source 15
PHUSE EU 2025 Bridging Languages: Building Integrated Analytical Tools with SAS, R, and Python for Clinical Data Margarethe Povey source
presentation source		 7
PHUSE EU 2025 Cracking the Curve: Unlocking Clinical Insights with Ridgeline Plots Mariam Babayan,
Rafik Ghazaryan		 source
presentation source		 6
PHUSE EU 2025 End-to-End R: Where To Start? Luke Thompson source
presentation source		 6
PHUSE EU 2025 FHIR for RWD Submissions: Why a US Regulation Signals a Global Shift And What You Need To Do Now Sanyogeeta Andhale,
Nachiket Thakkar		 source
presentation source		 11
PHUSE EU 2025 Framework for Integrating Omics Data with Other Clinical and NonClinical Data Sources Mehdi Harek,
Jonathon Keeney		 source
presentation source		 12
PHUSE EU 2025 From Outsourced to Open Source: Denalis R-Driven Transformation in Biometrics Michael Thorpe,
Thomas Neitmann		 source
presentation source		 4
PHUSE EU 2025 JSON for Submissions: Why You Should Care, What You Need To Know, and What To Do Now Bill Qubeck,
Sridhar Vijendra		 source
presentation source		 13
PHUSE EU 2025 Pooling Studies Through Code Traceability Hamdi Chouikha,
Kornelius Neufeld		 source
presentation source		 8
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 SAIL.R: Navigating Change Together in Clinical Analytics! Annemie Van Dijck source
presentation source		 11
PHUSE EU 2025 SAMBA: Bridging the Gap How GenAI Transforms Analysis Plans into ADaM Specs [presentation] Thiago Figueiredo,
Richard Becker		 source 19
PHUSE EU 2025 The Human Element: Synergising Emotional and Physical Intelligence in Statistical Programming Leadership Harris Kampouris,
Lino Jardim		 source
presentation source		 12
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 Visualising the Invisible: Patient Journey with Waterfall, Spider and Swimmer Plots Varsha Mithun Patil,
Sunita Poojary		 source
presentation source		 14
SESUG 2025 SAS and R in Action: Comparison of XPT File Creation Chen Ling 7
PharmaSUG 2025 An End-to-End Workflow for TFL Generation using R: MMRM Applications and Comparative Insights with SAS Kai Lei,
Jiaqiang Zhu,
Margaret Huang		 source 14
PharmaSUG 2025 Building Robust R Workflows: Renv for Version Control and Environment Reproducibility Junze Zhang,
Joshua J. Cook		 source 17
PharmaSUG 2025 Decoding the Role of Statistical Programming - A Decade of Keytruda Submissions and Approvals Mary N. Varughese,
Hong Qi		 source 8
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 Leveraging Health Technology Assessment (HTA) for Market Access: A Statistical Programming Perspective on German HTA Submission Rachana Agarwal,
Wendy Wang		 source 5
PharmaSUG 2025 Navigating the transition of legacy processes for SDTM creation Jyothi Ketavarapu source 5
PharmaSUG 2025 PDFs Done Right: The Statistical Programmer-s Guide to Flawless Regulatory Submissions Srivathsa Ravikiran,
Sri Raghunadh Kakani		 source 12
PharmaSUG 2025 Risk Mitigation Solution for Kaplan-Meier Plot in Drug Labeling Bingjun Wang,
Jane X. Liao,
Suhas R. Sanjee,
Jeff Xia		 source 13
PharmaSUG 2025 Slice, Dice, Analyze: Revolutionizing SDTM cuts with datacutr package Diego Madrigal Viquez source 6
PharmaSUG 2025 Towards an Integrated Submission-Ready Data Pipeline: Unifying Compliance, Automation, and Open-Source Innovation Shivani Gupta,
Bhavin Busa		 source 5
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 Understanding HIV: At-Risk Populations, Treatment, Prevention and Standardized Data Representation in HIV Studies Jyoti (Jo) Agarwal source 12
PharmaSUG 2025 Zero to Hero: The Making of a Comprehensive R Shiny Figures App Yi Guo,
Matthew Salzano,
Nicholas Sun,
Sean Healey		 source 30
PHUSE US 2025 AI Ethical Considerations in Drug Development and Regulatory Review Tara Chavda,
Qingying Ally Lu		 source
presentation source		 5
PHUSE US 2025 Changes to the Job of a Statistical Programmer in the Pharmaceutical Industry James J. Kim source
presentation source		 8
PHUSE US 2025 Collaborating on Standards: An Approach to Harmonizing Vaccine Regulatory Submissions Fred Bermont,
Médéric Celle,
Estella Sani,
Erin Gnas,
Jennifer Mastri,
Leslie Morgan,
Naila Musani,
Ramana Setty,
Sandra VanPelt Nguyen,
Yun Zhang		 source
presentation source		 8
PHUSE US 2025 Digital Health Technologies: Evolution, Insights and Future Directions [presentation] Vijay Pasapula source 28
PHUSE US 2025 E2E R Submission from a Roche Oncology Study Jingyuan Chen,
Hinal Patel		 source
presentation source		 6
PHUSE US 2025 Efficient TFL Review within Statistical Programming - Using R and SAS Siddharth Kumar source
presentation source		 8
PHUSE US 2025 eProtocol and the Promise of Automation Bill Qubeck,
Suhas Giriraj		 source
presentation source		 17
PHUSE US 2025 Evaluation of Open-Source Technologies in Clinical Trial Reporting Jaimin Patel source
poster source		 7
PHUSE US 2025 Expediting the Regulatory Submission Process Through Automated Tools Manish Deole,
Gautham Selvaraj		 source
poster source		 4
PHUSE US 2025 From Application to Approval: Exploring the FDA's Review Process Kiran Bonda 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 Harnessing the Power of R Shiny in a GxP-Compliant and Validated Manner for Clinical Trial Use Sanyogeeta Andhale,
Shilpa Sood		 source
presentation source		 13
PHUSE US 2025 Implementation of a risk-governed, reproducible, and collaborative R workflow for Real World Evidence Projects Ting Shi source
poster source		 8
PHUSE US 2025 Interactive Visualisation of Pooled Clinical Trial Safety Data Sara Bodach,
Ling Zhang		 source
presentation source		 7
PHUSE US 2025 Optimising AI Software for Automated Protection of Personal and Commercially Sensitive Data Honz Slipka source
poster source		 7
PHUSE US 2025 Optimising Collaboration and Quality Control in Outsourced Statistical Programming Mukesh Patel,
Nilesh Patel		 source
presentation source		 7
PHUSE US 2025 Optimising Regulatory Submissions: The Role of eCTD, Real-World Evidence and AI Kishore Pothuri source
presentation source		 5
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 R Package Risk Assessment: Balancing Programmatic and Human Input Chelsea Dickens source
presentation source		 4
PHUSE US 2025 Regulatory Challenges and Strategies for AI/ML-Enabled Medical Device (SaMD) Data Submission Shashikant Kumar,
Mrityunjay Kumar		 source
presentation source		 12
PHUSE US 2025 Risk.assessr: A Tool for Assessing and Mitigating Risks with Open-Source R Packages in Clinical Trials Andre Couturier,
Edward Gillian		 source
presentation source		 10
PHUSE US 2025 Solving real-world data (RWD) reliability challenges for use in regulatory decision-making Tasha Nagamine source
presentation source		 5
PHUSE US 2025 Staying Out of the Ditch - How Governance Can Provide Your Team Guardrails Matt Tendler,
Chris McSpiritt		 source
presentation source		 5
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 Olympics of Data Ingestions Cathryn Herbst source
presentation source		 8
PHUSE US 2025 The Role of Quantitative Bias Analysis (QBA) in Ensuring the Reliability of Real-World Evidence (RWE) in Regulatory Submissions Brian Gillette,
Tasha Nagamine		 source
presentation source		 6
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 Using the USDM and Ensuring Governance and Traceability to unlock the potential of Real-World Data sources for regulatory submissions Berber Snoeijer source
presentation source		 12
PHUSE US 2025 Wearable Technology: Enhancing Patient Monitoring and Real-World Evidence Bill Qubeck,
Sridhar Vijendra		 source
presentation source		 15
PHUSE EU 2024 Ensuring Governance and Traceability of RWD from Source to Regulatory Submission: Use Case Michael Kolzet,
Berber Snoeijer		 source
presentation source		 12
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 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 {r}amnog: Towards a Common, Open-Source Solution for Programming AMNOG-Style EU-HTA Analyses Matthew Phelps,
Christian Olsen		 source
presentation source		 6
WUSS 2024 Will statistical programmers be replaced by Artificial Intelligence? [presentation] Junying Zhang source 20
PharmaSUG CN 2024 Roche automated esub translation Joe Zhu,
Xiaoli Duan,
Siye Liu		 source 3
PharmaSUG 2024 Cultivating Success with Non-standard Investigator-sponsored Trial Data for FDA Submissions Jai Deep Mittapalli,
Jinit Mistry,
Venkatesulu Salla		 source 9
PharmaSUG 2024 Navigating Success: Exploring AI-Assisted Approaches in Predicting and Evaluating Outcome of Clinical Trials and Submissions Ruohan Wang,
Chris Qin		 source 9
PharmaSUG 2024 Optimizing Clinical Data Processes: Harnessing the Power of Metadata Repository (MDR) for Innovative Study Design (ISD) and Integrated Summary of Safety (ISS) / Efficacy (ISE) Lakshmi Mantha,
Purvi Kalra,
Arunateja Gottapu		 source 9
PharmaSUG 2024 Piloting into the Future: Publicly available R-based Submissions to the FDA Benjamin Straub source 9
PHUSE US 2024 Data Pipeline - Improving Cycle Time and Shifting Data Closer to Analytics Jayasree Ivaturi source
presentation source		 6
PHUSE US 2024 Data Quality Evaluation of EHR FHIR API Real-World Data for FDA and Pharmaceutical Industry Use for Analysis and AI Implementation Sarah Ferko,
Abhishek Pandey,
Matthew Deady,
Brian Goodness		 source
presentation source		 10
PHUSE US 2024 Exploring the Potential Use of Generative AI in the Regulatory Review Process [presentation] Qingying Ally Lu,
Kathryn Matto		 source 19
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 The Knowledge Graph - The Power of an Information Network driving Biometric workflows Nekzad Shroff,
Jaya Simha Inampudi		 source
presentation source		 3
PHUSE US 2024 Usage of OMOP-CDM along with CDISC in Clinical Trials: Challenges and Opportunities Parag Shiralkar source
presentation source		 5
PHUSE EU 2023 Avoid Major Pitfalls When Using Real-World Evidence (RWE) in Regulatory Submissions Alex Ide,
Mark Lambrecht		 source
presentation source		 3
PHUSE EU 2023 Unleashing the Power of Large Language Models for Clinical Data Approaches: Will AI chatbots like ChatGPT/Bard replace statistical programmer and statisticians over time? Ercan Suekuer source
presentation source		 9
WUSS 2023 Demystifying the define.xml: Overcoming the challenges of CRT Package. Yoganand Budumuru source 10
PharmaSUG 2023 A utility to combine study outputs into all-in-one PDF for DSUR Wei Shao source 8
PharmaSUG 2023 Auto-validation of SAS Macros through Regression Testing Madhu Annamalai,
Umayal Annamalai		 source 5
PharmaSUG 2023 Automated Mockup Table and Metadata Generator Jeff Cheng,
Shunbing Zhao,
Guowei Wu,
Suhas R. Sanjee		 source 12
PharmaSUG 2023 Consistency Checks Automation across Regulatory Submission Documents in the eCTD M5 folder Majdoub Haloui,
Loganathan Ramasamy,
Hemu Shere		 source 8
PharmaSUG 2023 Key Statistical Programming Considerations in External Collaborative Clinical Trials James Zhao,
Hong Qi,
Mary N. Varughese		 source 4
PharmaSUG 2023 Validating novel maraca plots - R and SAS love story Nicole Major,
Srivathsa Ravikiran,
Monika Huhn,
Samvel Gasparyan,
Martin Karpefors		 source 17
PHUSE US 2023 Computerised Algorithm for Multiple Myeloma Response Assessments Mahesh Swaminathan source
presentation source		 3
PHUSE US 2023 Innovate Clinical Trial Reporting with Open Source Soma Sekhar Sriadibhatla,
Francis Kendall		 source
presentation source		 4
PHUSE US 2023 Managing Deliverables in Oncology Basket Trials Hong Qi,
Mary N. Varughese		 source
presentation source		 6
PHUSE US 2023 Using Real-world Data and Synthetic Data to Predict Study Outcomes, Submission Performance and Market Effectiveness [presentation] Jose C. Lacal,
Stuart Malcom		 source
video		 15
PHUSE US 2023 Working Together: The Evolving Relationship of Biostatistics & Regulatory for Support of Study Data Standardization Plans and BIMO Reviewer's Guides David C. Izard source
presentation source		 3
PHUSE EU 2022 Is Your Analytics Platform Ready for Handling Real-world Data for Regulatory-grade Real-world Evidence? William Kuan,
Olivier Bouchard		 source
presentation source		 7
WUSS 2022 A Statistical Programmer's Growth Journey: It is More than Learning New Code Janette Garner source 6
PharmaSUG 2022 A SAS Macro to Aid Assembly Review of M5 Module in Submission Jeff Xia source 5
PharmaSUG 2022 Just Say No to Data Listings! Mercidita Navarro,
Nancy Brucken,
Aiming Yang,
Greg Ball		 source 4
PHUSE US 2022 High-quality COVID Vaccine Submission at Lightning Speed [presentation] Helen Yang,
Kiran Challagali		 source 9
PHUSE US 2022 Introducing Reporting Packages in R for TFLs [presentation] Pavan Reddy,
Thomas Kalfas		 source
video		 12
PHUSE US 2022 Just Say No to Data Listings! [poster] Maria Dalton source 1
PHUSE US 2022 Statistical Programming Operational Review Dashboard [presentation] Kathleen J. Harkins,
Shuqi Zhao		 source
video		 16
PHUSE US 2022 Staying Ahead of the Curve: The Future Direction of Modernization of Statistical Analytics (MSA) [presentation] Peter Mesenbrink source 19
PHUSE US 2022 Using AI-based Technology to Accelerate Clinical Trial Data Sharing and Reuse [presentation] Ron Kaine,
Thomasin Element		 source
video		 33
PHUSE EU 2021 Methods and Challenges of R Validation for Regulatory Submission Analysis [presentation] Parvee Kumar source
video		 14
PHUSE EU 2021 Standing Room Only: SA04: Diversity, Equity and Inclusion of Your Submission Package [presentation] Anne-Sophie Bekx source 19
PHUSE US 2021 Generating .xpt files with SAS, R and Python [presentation] Todd Case source
video		 22
PHUSE US 2021 Regulatory Update & Townhall [presentation] Ethan Chen source 28
PHUSE US 2021 Statistical Programming Team Contributions to Registrational Clinical Research Collaborations (rCRCs) [poster] Norihiko Oharu,
Yan Shen		 source 1
PHUSE US 2021 Using Natural Language Processing to Create Subject Safety Narratives [presentation] Frank Meloni,
Tim Willittes		 source
video		 8
PharmaSUG 2021 A TransCelerate Initiative - how can you modernize your statistical environment? Vincent J. Amoruccio,
Min Lee,
Daniel Woodie		 source 16
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
PHUSE EU 2020 Don't UnderMine the Value of Your CRF - with Perl Regular Expressions [presentation] John McDade source
video		 22
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 Innovation in Exploratory/Regulatory Clinical Trial Analyses [presentation] Tadeusz Lewandowski source
video		 31
PharmaSUG 2020 Analysis Package e-Submission - Planning and Execution Abhilash Chimbirithy,
Saigovind Chenna,
Majdoub Haloui		 source 8
PharmaSUG 2020 Supplementary Steps to Create a More Precise ADaM define.xml in Pinnacle 21 Enterprise Majdoub Haloui,
Hong Qi		 source 10
PharmaSUG 2020 SUPPQUAL Datasets: Good Bad and Ugly Sergiy Sirichenko source 14
PHUSE US 2020 Automating Module 5 Packaging with Customizable Metadata Dhananjay Chhatre,
Kevin Miller		 source
presentation source		 6
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 Statistical Programming Team Contributions for RWE Regulatory Submissions Lin Gao,
Norihiko Oharu		 source
poster source		 1
PHUSE US 2020 SUPPQUAL Datasets: Good Bad and Ugly Sergiy Sirichenko,
Blue Bell		 source
presentation source		 13
PHUSE US 2020 The Misery of the Miscellaneous Folder in Module 5 Marguerite Kolb source
presentation source		 8
PHUSE EU 2019 Utilising RWD and RWE: An Introduction to Core Concepts and Requirements Christopher C. Hurley,
Aditya Gadiko		 source
presentation source		 7
SESUG 2019 One Click to Analysis Results Metadata Srivathsa Ravikiran,
Priscilla Gathoni		 source 18
WUSS 2019 Python applications in SAS programming for medical device clinical trial studies Jianlin Li source 7
PharmaSUG 2019 Updates on validation of ADaM data Sergiy Sirichenko source 9
PHUSE US 2019 CDISC Doesn't Tell You What to Collect But Regulators Do! Diane Wold source
presentation source		 4
PHUSE US 2019 Developing, Implementing and Governing End-to-End Standards at Gilead Dhananjay Chhatre source
presentation source		 5
PHUSE US 2019 DR3 - A Tool to Create Define-XML (SDTM/ADaM with ARM) [presentation] Eric Weising source 7
PHUSE US 2019 Machine-readable Data Not Required for the EMA...Really? David C. Izard source
presentation source		 4
PHUSE US 2019 Send 3.1: Giving Your Submission a 'Vital' Upgrade Megan Bausman,
Mikayla Simons		 source
presentation source		 6
PHUSE US 2019 The Benefits, Challenges and Myths of SEND Bill Houser,
Lou Ann Kramer		 source
presentation source		 8
PHUSE EU 2018 The Role of a Project Programmer Within GSK Nadeem Gul,
Sheetal Patel		 source
presentation source		 6
PHUSE EU 2018 Updates on validation of ADaM data Max Kanevsky,
Sergiy Sirichenko		 source
presentation source		 7
PHUSE US 2018 Achieving Highest Quality and Usability of SEND through Industry and Regulatory Collaboration William Houser,
Lou Ann Kramer		 source 7
PHUSE US 2018 Qualitative Analysis of Actual SEND Datasets for Trial Design Domains [poster] G. Sato source 1
PHUSE US 2018 Ready Set Go: Planning and Preparing a CDISC Submission Maria Dalton source
presentation source		 11
PharmaSUG 2018 Mind Over Matter: Building an Army of Passionate Soldiers Dedicated to Saving Patients' Lives Shefalica Chand source 10
PHUSE EU 2017 CDISC Transport Standards - A Glance Edwin Ponraj Thangarajan,
Giri Balasubramanian		 source
presentation source		 14
PharmaSUG 2017 Common Programming Errors in CDISC data Sergiy Sirichenko source 9
PharmaSUG 2017 Good Data Validation Practice Sergiy Sirichenko,
Max Kanevsky		 source 10
PHUSE EU 2016 Planning for Data Reporting Processes for Submission: Key Considerations Parag Shiralkar source
presentation source		 2
PHUSE EU 2016 What is high quality study metadata? Sergiy Sirichenko,
Max Kanevsky		 source
presentation source		 9
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 What is high quality study metadata? Sergiy Sirichenko,
Max Kanevsky		 source 9
PHUSE EU 2015 Constructing a Simple Data Repository [presentation] Magnus Mengelbier source 19
SESUG 2015 Reporting of treatment emergent adverse events based on pooled data Analysis or Country Specific Submissions: A case study Sheetal Shiralkar source 8
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 The Most Common Issues in Submission Data Sergiy Sirichenko,
Max Kanevsky		 source 9
PharmaSUG 2015 Tips on Creating a Strategy for a CDISC Submission Rajkumar Sharma source 5
PHUSE EU 2014 A Day in the Life of a Data Sharing Specialist [presentation] Kelly Mewes source 29
PHUSE EU 2014 Models, Metadata and Messaging: Exploring Standards Governance in the CDISC Era Kenneth Stoltzfus source
presentation source		 6
PharmaSUG 2014 Clinical Trial Data Integration: The Strategy, Benefits, and Logistics of Integrating Across a Compound Natalie Reynolds,
Keith Hibbetts		 source 12
PharmaSUG 2014 SAS as a Tool to Manage Growing SDTM+ Repository for Medical Device Studies Julia Yang source 12
PHUSE EU 2013 ProjectTrackItL Automate your Project using SAS Abhishek Bakshi source
presentation source		 9
PHUSE EU 2013 Standards for the Management of Clinical Trial Data, Why are they Needed, What is Needed? Isabelle Abousahl source
presentation source		 11
PharmaSUG 2013 A Drug Safety Reporting System in SAS Yang Wang,
Shawn Hopkins,
Norm Fox,
Raghu Kumbharathi,
Tom Hunter		 source 7
PharmaSUG 2012 "Analysis-ready" - Considerations, Implementations, and Real World Applications Ellen (Zihui) Lin,
Beiying Ding		 source 6
PharmaSUG 2012 Creating Define.pdf with SAS Version 9.3 ODS RTF Elizabeth Li,
Carl Chesbrough		 source 36
PHUSE EU 2010 Statistical Graphics for Review and Reporting in Clinical Development Kerstin Pietzko,
Michael O'Connell		 source
poster source		 12
WUSS 2008 Seven Steps to Regulatory Publication Style with PROC REPORT Dennis Gianneschi source 6
PharmaSUG 2008 A regulatory submission "DEFINE"d: The who, where, and what Robby A. Diseker,
Lindsay Dean		 9
PharmaSUG 2008 Cost-Effective Solution to Automating the Creation of CDISC define.xml: Using SAS Data _Null_ with Relational Data Model via SAS/AF Application Annie S. Guo 12
PharmaSUG 2008 SDTM, Plus or Minus Barry R. Cohen 6
PharmaSUG 2007 Automated Way to Develop Data Definition Document for Regulatory Submission Mustaq Ahmad 11
PharmaSUG 2007 How to Migrate a Moving Target Paul B. Jarrett 3
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 Navigating a Major Regulatory Submission Project to Success Alan Meier source 6
SGF 2007 Seven Steps to Regulatory Publication Style with PROC REPORT Dennis Gianneschi source 6
NESUG 2006 Developing and Managing a SAS Macro Library Carolyn Maass,
Margaret James,
Ginger Redner		 8
PharmaSUG 2006 Developing and Managing a SAS Macro Library Margaret James,
Carolyn Maass,
Ginger Redner		 7
PharmaSUG 2006 Perfecting the Publishing Process with SAS 9.1.3 P. Chris Holland 12
PHUSE EU 2005 An Introduction to CDISC - What is CDISC and Why Standards? Laurie Rose,
Becky Kush		 source 41
PHUSE EU 2005 The Future of CDISC Becky Kush source 50
PharmaSUG 2005 A Simple Solution for Managing the Validation of SAS Programs That Support Regulatory Submissions Tony Chang,
Dana Soloff		 6
PharmaSUG 2005 To Macro or Not To Macro? Amy Gillespie,
Blue Bell		 8
PharmaSUG 2004 Automation of Patient Narratives Using SAS and Analysis Datasets David C. Izard 6
PharmaSUG 2004 Build Portable Structures and Programs for Electronic Regulatory Submissions Wei Cheng 6
NESUG 2003 Overview of a Browser-Based Clinical Report Generation Tool Gregory T. Weber,
Paul M. Gilbert		 6
NESUG 2002 Focusing on Our New Deliverables--CRT and Analysis Data Sets Phebe Joseph 8
PharmaSUG 2002 Design Considerations Used to Develop Clinical Reporting Software Steven Light,
Paul M. Gilbert		 4
PharmaSUG 2002 Preparing the SAS Software Programming Environment for Regulatory Submission Sunil Kumar Gupta 10
NESUG 2001 Standards for Electronic Submissions to FDA Kay Obenshain 3
PharmaSUG 2001 FDA Reviewers as Ultimate End Users: Using the SAS System to Construct e-Submissions that Actually Facilitate the NDA / BLA Review Process Rich Vachal 6
PharmaSUG 2001 Standards for Electronic Submissions to FDA Kay Obenshain 4
SUGI 2001 Preparing the SAS Software Programming Environment for Regulatory Submission Sunil Kumar Gupta source 9
NESUG 2000 New Technology, New Opportunities: XML and SAS Automate Statistical Tables Michael C. Palmer,
Cecilia A. Hale		 6
SUGI 2000 Preparing the SAS Software Programming Environment for Regulatory Submission Sunil Kumar Gupta source 5
PharmaSUG 1998 Identifying and Reporting of Medically Serious Adverse Events: An Interactive Approach Anna Kunina,
Palo Alto		 3
SUGI 1993 Facilitating Clinical Data Management and Regulatory Review in the Pharmaceutical Industry: A Manager's Perspective Randi Olsen McFarland source 2

Back to keywords