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21 cfr part 11

39 papers and 14 presentations; 52 titles.

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Conference × Year × Title × Authors Extras Pages
PHUSE US 2026 DevOps for Clinical Data Science: A Leap into the Future of Clinical Analysis Frikkie Oppel,
Riaan Van Straaten		 source
presentation source		 6
PHUSE US 2026 R We There Yet? A Readiness-Assessment Framework for Adoption of R and Open-Source Solutions Narasimhan Kaliyamoorthy source
presentation source		 7
PHUSE US 2026 Validation Strategies for Agentic AI Platforms in GxP-Regulated Clinical Data Environments Rajesh Hagalwadi source
presentation source		 9
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 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 Validated Statistical Computing: A Kubernetes Framework for Regulatory-Compliant R, Python and SAS Deployments T. Randall Betancourt,
Tim Fantuzzo		 source
presentation source		 53
PharmaSUG 2025 Navigating the transition of legacy processes for SDTM creation Jyothi Ketavarapu source 5
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 Navigating the Transition to a New Statistical Computing Environment: Streamlining Compliance and Operational Excellence Shilpa Sood,
Kala Shivalingaiah		 source
poster source		 11
PHUSE US 2025 Wearable Technology: Enhancing Patient Monitoring and Real-World Evidence Bill Qubeck,
Sridhar Vijendra		 source
presentation source		 15
PharmaSUG 2024 Adding the missing audit trail to R Magnus Mengelbier source 8
PHUSE US 2024 Whodunnit? Automation Tools Accelerate Statistical Analysis in an SCE with Full Compliance [presentation] Shivoy Pandita,
Jörn Bilow		 source 13
PHUSE US 2023 Visual Guidance: Monitoring Data Fitness and Study Progress in an SCE [presentation] Jörn Bilow source
video		 12
PHUSE EU 2022 Collaboration Between Analytical Health Care Technology Leaders will Positively Impact Clinical Trial Research Innovation & Improve Health Care System [presentation] Mark Lambrecht,
Andrew Warrington		 source
video		 19
PHUSE US 2022 A Day on the Fast Track: How a Statistical Computing Environment Helps to Streamline Programming [presentation] Jörn Bilow source
video		 14
PHUSE EU 2021 Methods and Challenges of R Validation for Regulatory Submission Analysis [presentation] Parvee Kumar source
video		 14
PHUSE EU 2021 Software Demonstration: Freedom or Regulatory Compliance? Have Both, in a Language-agnostic Statistical Computing Environment - Sponsored by Entimo [presentation] Jörn Bilow source 14
PHUSE US 2021 Software Demonstration: SD08: entimICE FastTrack Next Generation Statistical Computing Environment [presentation] Jörn Bilow source 17
PHUSE EU 2020 The Validation of Open-source Tools for Clinical Statistics and Programming [presentation] Ali Dootson,
Richard Pugh		 source
video		 21
SGF 2020 SAS Knows Good Manufacturing Practice Lois Wright source 11
PHUSE US 2020 Regulatory Scrutiny on Data Integrity: Are You Safe? Chris Decker,
John Horton		 source
presentation source		 11
PharmaSUG 2018 Making the most of SAS Jobs in LSAF Gregory T. Weber,
Sonali Garg		 source 5
PHUSE EU 2017 Git with It and Version Control! Carrie Dundas-Lucca,
Ivan Gomez		 source 6
PHUSE EU 2014 Clinical Study Data Processes @ LEO Pharma Joergen Iversen source
presentation source		 4
PHUSE EU 2014 WISE a World Wide Integrated SAS Environment for Today and Beyond [presentation] Alain Vasseur,
Christelle Le-Beaudour		 source 22
WUSS 2013 Building a Controlled Statistical Programming Environment Wayne F. Woo source 10
PharmaSUG 2013 Managing 21 CFR Part 11 Compliance: Using Checksums on Opens Systems Carey G. Smoak,
Mario Widel		 source 8
PHUSE EU 2011 "Overnight" Conversion to SDTM Datasets - Ready for SDTM Submission Niels Mathiesen source
presentation source		 7
SGF 2010 Why Arent You Using MEMLIB? Erik H. Dilts source 3
PHUSE EU 2009 Implementation of CDISC Standards at Nycomed [presentation] Berthold Traub source 31
PharmaSUG 2009 Medical Coding System for Clinical Trials - 21 CFR Part 11 Compliant SAS/AF Application Annie S. Guo 12
PHUSE EU 2007 Check for SAS files consistency Arnaud Dauchy source 29
PHUSE EU 2005 An Introduction to CDISC - Available CDISC Standards and Models and How SAS Supports These Laurie Rose source 43
PHUSE EU 2005 ODM & define.xml David Iberson-Hurst source 58
PHUSE EU 2005 Software Tools for working with CDISC ODM, SDTM, LAB and define.xml Jozef Aerts source 2
WUSS 2004 Implementing an Audit Trail within a Clinical Reporting Tool Paul M. Gilbert,
Troy A. Ruth,
Gregory T. Weber		 source 7
PharmaSUG 2004 Implementing an Audit Trail within a Clinical Reporting Tool Paul M. Gilbert,
Troy A. Ruth,
Gregory T. Weber		 6
SESUG 2003 Data Acquisition Portal (DAP) Web: Web Based Data Collection Application Christina Carty,
Elizabeth R. Spence,
Norman Oals,
Linda Linzy,
Reuben Richards		 source 4
MWSUG 2003 Addressing 21 CFR Part 11 Concerns with Execution and Repository Control Curt Wehrley,
Donald L Penix Jr.,
Wing Lam		 8
NESUG 2003 Date/Time Stamped Files and Audit Trails: What Part 11 Compliant SAS Systems are Made Of Carolyn Dougherty 11
NESUG 2003 Overview of a Browser-Based Clinical Report Generation Tool Gregory T. Weber,
Paul M. Gilbert		 6
PharmaSUG 2003 A Programming Development Environment for SAS Programs Tim P. Williams 8
PharmaSUG 2003 Overview of a Browser-Based Clinical Report Generation Tool Paul M. Gilbert,
Gregory T. Weber,
Teofil Boata		 6
PharmaSUG 2003 Producing Structured Reports in a Regulated Environment Using SAS - Meeting 21 CFR Part 11 Andrew Lawton,
Michael Pearce		 6
SUGI 2003 A Programming Development Environment for SAS Programs Tim P. Williams,
Lee Walke		 source 6
SESUG 2002 A Programming Development Environment for SAS Programs Tim P. Williams source 10
SEUGI 2002 SAS and the CRO [presentation] Peter Stagg source 14
SEUGI 2002 SAS Drug Development: Intelligent Research Management [presentation] Andrew T. Fagan source 18
PharmaSUG 2002 SAS Coexistence with FDA 21 CFR Part 11, How Far Can We Get? Gustav Sporon-Fiedler,
Marie Lassen		 6
PharmaSUG 2002 SAS Solutions for Addressing 21 CFR Part 11 Compliance - the P21 Biomedical Knowledge Platform Edward D. Helton 6
VIEWS 2001 From Data Entry to e-submission - only a button away with SAS. Integrated Clinical trial reporting - Oracle Clinical, SAS and Documentum [presentation] Andrew Lawton,
Michael Pearce		 16
SEUGI 2001 The SAS/UK Clinical Data Management Knowledge Solution [presentation] Ian Pimblett source 23
PharmaSUG 2001 Security Issues for Web-based Applications: Issues and solutions for the safe transfer of Clinical Trials data over the Internet Andrew T. Fagan,
Christopher R. Olinger		 6

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