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157 papers and 14 presentations; 161 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2026 An Experience Using R, SASSY and Tidyverse For Clinical Trial Analysis, From A SAS Programmer Perspective David W. Franklin source 27
PharmaSUG 2026 Closing the Loop: Validating AI-Generated SDTM Mappings using CDISC CORE and Synthetic Data Pietro Belligoli,
Constantin Weberpals,
Yarhy Flores Lopez		 source 7
PharmaSUG 2026 Virtual Data, Real Standards: Leveraging Data Simulation for Smarter Clinical Trials Sangeeta Shabadi,
Nitesh Patil,
Jonathan Henshaw		 source 16
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 Incorporating Digital Health Technology (DHT) Data in SDTM - Challenges and Examples Swarupa Sudini,
Sandra VanPelt Nguyen		 source
poster source		 7
PHUSE US 2026 Integrated Summary of Safety (ISS) Demystified: Practical Considerations for a Successful ISS Ji Qi,
Lily Cheng		 source
presentation source		 8
PHUSE US 2026 Safety at a Glance: Enhancing Participant Monitoring in Oncology Trials with Data Visualisation Agnieszka Bel source
presentation source		 10
SESUG 2025 Perfect Patient Profiles in SAS using ODS and the Graph Template Language (GTL) Joshua M. Horstman,
Richann J. Watson		 38
PharmaSUG 2025 Advanced Programming with R: Leveraging Tidyverse and Admiral for ADaM Dataset Creation with a Comparison to SAS Joshua J. Cook,
Richann J. Watson		 source 20
PharmaSUG 2025 Name That ADaM Dataset Structure Nancy Brucken source 8
PHUSE US 2025 Considerations for the Submission of RWD using CDISC with Insights from HL7 FHIR and OMOP Ingeborg Holt,
Sarah Ferko,
Jeffrey M. Abolafia		 source
presentation source		 15
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 Interactive Dashboards - Empowering Clinicians to Generate Reports Instantly Inderjeet Arora source
presentation source		 8
PHUSE EU 2024 Harmonising FDA and PMDA Submission Requirements Luca Semeraro source
presentation source		 12
PharmaSUG CN 2024 CDASH-SDTM Combo Model in SDTM Automation Chunpeng CZ Zhao source 11
PharmaSUG 2024 aCRF Copilot: Pioneering AI/ML Assisted CRF Annotation for Enhanced Clinical Data Management Efficiency Chaitanya Pradeep Repaka,
Santhosh Karra		 source 7
PharmaSUG 2024 An Introduction to the SAS Transpose Procedure and its Options Timothy J. Harrington source 14
PharmaSUG 2024 Bridging AI and Clinical Research: A New Era of Data Management with ChatGPT Illia Skliar source 12
PHUSE US 2024 My Data Are Too Good to Be True! Should I Worry About Fraud or Sloppiness? Johann Proeve source
presentation source		 9
PHUSE EU 2023 Patient Profiles v2.0: Easy and Quick Clinical Trial Insights in Tableau Roman Radelicki,
Annelies Van Zeveren		 source
presentation source		 6
PHUSE US 2023 Practical Application of Multiple Screenings/Enrollments Martha O'Brien,
Proma Debnath		 source
presentation source		 4
PHUSE US 2023 SDTM Mapping Recommendation Engine - Acorn [presentation] Rohan Parmar,
Harshit Manektalia		 source
video		 32
PHUSE EU 2022 Finding Anomalies and Outliers in Clinical Trial Time Series Data Pekka Tiikkainen source
presentation source		 6
PHUSE EU 2022 The Development of CDISC Biomedical Concepts: Update and Next Steps [presentation] Bess LeRoy source
video		 35
WUSS 2022 Quick Jumpstart into Pharmaceutical SAS Programming Jim Box,
Matthew J. Becker		 source 7
PHUSE US 2022 Using odmlib to Create ODM and Define-XML Tools in Python Samuel Hume source
presentation source		 6
PHUSE US 2021 CSR Narratives Automation [presentation] Ritesh Dhimmar source
video		 23
PHUSE US 2021 How Will Knowledge Graphs Improve Clinical Reporting Workflows? [presentation] Alexey Kuznetsov,
Jorine Putter		 source 9
PHUSE US 2021 Protocols on FHIR - Exchanging Study Designs with EHR Systems [presentation] Andy Richardson,
Geoffrey Low		 source
video		 24
PHUSE US 2021 Visualizations to Support DSMB Monitoring [presentation] Derek Coombs source
video		 14
PharmaSUG 2021 An efficient method to review annotation and create bookmark for case report form (acrf.pdf) using SAS program, FDF files, excel and Javascript in Acrobat Chen-Jung Wu source 12
PharmaSUG 2021 Biomedical Concepts - An Emerging CDISC Data Standard: A Stepwise Approach for Building a Library of Data Definitions Kirsten Langendorf,
Johannes Ulander		 source 15
PharmaSUG 2021 Generating FDA-ready Submission Datasets directly from EHRs Jozef Aerts source 9
PHUSE EU 2020 Catch Them When You Can ... Fix Them [presentation] Anna Panasenko source
video		 23
PHUSE EU 2020 Novel eCRF Study Template to Support Adaptive Design Studies in Medidata Rave [presentation] Nele Claes,
Ray Lacchman		 source
video		 29
PHUSE EU 2020 The Good? The Bad? Or the Ugly? CDISC eSubmission Packages in Practice [presentation] Artur Krupa source
video		 26
PharmaSUG 2020 A SAS Macro for Dynamic Assignment of Page Numbers Manohar Modem,
Bhavana Bommisetty		 source 10
PharmaSUG 2020 Transpose Procedure: Turning it Around Again Janet E. Stuelpner source 8
PHUSE US 2020 Quarterly Safety Reporting: Timely Analysis of Clinical Safety Data Using Qlik Sense Software Yvonne Denkins source
presentation source		 8
PHUSE US 2020 The JumpStart Traceability Assessment Tejas Patel,
Sarah Ferkov		 source 10
PHUSE US 2020 Titles Are a Programmer's Best Friend Gregory Nunn source
poster source		 5
PHUSE EU 2019 A Data-driven and cost-effective approach towards Risk Based Monitoring Vineet Jain source
presentation source		 7
PHUSE EU 2019 Challenges Involved with Using Legacy Clinical Trial Study Data During Integration Adebola Opasanya source
poster source		 8
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
PHUSE US 2019 An Open Clinical Data Quality Framework Vineet Jain source
presentation source		 11
PHUSE US 2019 Don't Let Your Data Handle You: A Novel Approach to Clinical Programming Jorine Putter source
presentation source		 10
PHUSE US 2019 Formedix On: Advanced Metadata Management Now With Data! [presentation] Kevin Burges,
Steven Benham		 source 45
PHUSE US 2019 Managing Complexity Towards Submission Johannes Ulander source
presentation source		 26
PHUSE US 2019 Send 3.1: Giving Your Submission a 'Vital' Upgrade Megan Bausman,
Mikayla Simons		 source
presentation source		 6
PHUSE US 2019 Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis Priya Gopal source
presentation source		 12
PHUSE EU 2018 Easing Your Pain with Biomedical Concepts Kirsten Langendorf source
presentation source		 12
PHUSE EU 2018 How Machine Learning Can Automate Data Standardization in Clinical Trials [presentation] Fanyi Zhang source 16
PHUSE EU 2018 Please Put Your Data in an Upright Position - Or How to Tackle Verticalisation Kristina Zweier source
presentation source		 9
PHUSE EU 2018 Turning Fantasy into Reality - Creating Custom Data Visualisations for Future Reporting James Diserens source
presentation source		 11
PHUSE EU 2018 Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API Samuel Hume,
Geoff Low		 source
presentation source		 12
MWSUG 2018 An Update on the CS Standard Analyses and Code Sharing Working Group Nancy Brucken,
Jared Slain		 4
PHUSE US 2018 Adverse Event Analysis - One step forward! Anuja Rasal source
presentation source		 11
PHUSE US 2018 Easing Your Pain with Biomedical Concepts Kirsten Langendorf source
presentation source		 13
PHUSE US 2018 Transforming Clinical Trials with Linked Data Tim P. Williams,
Armando Oliva		 source
presentation source		 9
PharmaSUG 2018 Advanced Visualization using TIBCO Spotfire and SAS Ajay Gupta source 14
PharmaSUG 2018 Building Simulated CRF Data for Study Mock-Ups Ashley Kesler,
Hisham Madi,
Jonathan W. Duggins,
James E. Blum		 source 10
SGF 2018 Navigating through Code with the DATA Step Debugger Mina Chen source 13
SESUG 2017 Clinical Data Visualization using TIBCO Spotfire and SAS Ajay Gupta source 12
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 Helping The Define.xml User David Iberson-Hurst source
presentation source		 12
PHUSE EU 2017 Robust Study Database Build: An Effective Start Towards Creation of Quality SDTMs Onkar Tajarekar source
presentation source		 9
PHUSE EU 2017 The Art of Data Visualization: DetectingMultivariate Data Outliers Using an Interactive Approach Diane Peers source
presentation source		 9
PHUSE EU 2017 Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real-World Evidence Trisha Simpson,
Regina Zopf		 source
presentation source		 12
WUSS 2017 A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices Carey G. Smoak source 16
PharmaSUG CN 2017 Constructive Practice of Generating ADaM Datasets Amos Shu 7
PharmaSUG 2017 A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices Carey G. Smoak source 16
PharmaSUG 2017 Clinical Data Visualization using TIBCO Spotfire and SAS Ajay Gupta source 12
SGF 2017 A Critique of Implementing the Study Data Tabulation Model (SDTM) for Drugs and Medical Devices Carey G. Smoak source 16
SESUG 2016 Are You Sure That Is Correct?: An Overview Of Good Practices For Dataset And Output Validation Gregory Weller source 8
SESUG 2016 Dynamically Setting Decimal Precision Using PUTN Brandon L. Welch source 6
SESUG 2016 SDTM What? ADaM Who? A Programmer's Introduction to CDISC Venita DePuy source 9
PHUSE EU 2016 Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real World Evidence (RWE) Regina Zopf,
Jeffrey M. Abolafia,
Bhargava Reddy		 source
presentation source		 12
MWSUG 2016 Array of Sunshine: Casting Light on Basic Array Processing Nancy Brucken 5
PharmaSUG 2016 Array of Sunshine: Casting Light on Basic Array Processing Nancy Brucken source 5
PharmaSUG 2016 Efficient Safety Assessment in Clinical Trials using the Computer-generated AE Narratives of JMP Clinical Richard C. Zink,
Drew Foglia		 source 13
SGF 2016 Analytics of Things: Golf a Good Walk Spoiled? David Shannon source 15
PHUSE EU 2015 Efficient Data Reviews and Quality in Clinical Trials Using CDISC Data Standards Valérie Nedbal source 11
PHUSE EU 2015 WPP, Worst Programming Practice - Real-life Pittfalls in Everyday Clinical Programming: Why and How Hannes Engberg Raeder,
Rowland Hale		 source
presentation source		 14
PharmaSUG CN 2015 Generic Macros for Data Mapping Qian Zhao,
John Wang,
Ruofei Hao		 9
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 Generic Macros for Data Mapping Qian Zhao,
Jun (John) Wang,
Ruofei Hao		 source 9
PharmaSUG 2015 Techniques of Preparing Datasets for Visualizing Clinical Laboratory Data Amos Shu,
Victor Sun		 source 6
SESUG 2014 SDTM What? ADaM Who? A Programmer's Introduction to CDISC Venita DePuy source 9
PHUSE EU 2014 From ODM to SDTM: An End-to-End Approach Applied to Phase I Clinical Trials Alexandre Mathis source
presentation source		 5
PHUSE EU 2014 Signal Detection of Misconduct in Clinical Trials Geoffrey A. Mann,
Richard C. Zink		 source
presentation source		 7
PharmaSUG 2014 Building Better Programming Teams with Situational Exposure Training Elizabeth Reinbolt,
Steven R. Kirby		 source 3
PharmaSUG 2014 CDISC Mapping and Supplemental Qualifiers Arun Raj Vidhyadharan,
Sunil Mohan Jairath		 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 Risk-Based Monitoring of Clinical Trials Using JMP Clinical Richard C. Zink,
Kelci J. Miclaus		 source 15
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 Risk-Based Monitoring of Clinical Trials Using JMP Clinical Richard C. Zink source 14
SESUG 2013 Patient Profile Graphs Using SAS Sanjay N. Matange source 14
PHUSE EU 2013 Developing an Integrated Platform, Getting the Best out of Several Technologies [presentation] Jean-Marc Ferran,
Bart Van Win		 source 23
PHUSE EU 2013 Visual Approaches for Safety Analysis and Review of Clinical Trials [presentation] Valérie Nedbal source 34
MWSUG 2013 Beating Gridlock: Parallel Programming with SAS Grid Computing and SAS/CONNECT Jack E. Fuller 7
PharmaSUG 2013 Patient Profile Graphs Using SAS Sanjay N. Matange source 14
PharmaSUG 2013 SAS GTL: Improving Patients Safety and Study Efficiency Masaki Mihaila source 11
PharmaSUG 2013 Traceability in the ADaM Standard Ed Lombardi source 8
SGF 2013 Patient Profile Graphs Using SAS Sanjay N. Matange source 14
SESUG 2012 Developing a Complete Picture of Patient Safety in Clinical Trials Richard C. Zink,
Russell D. Wolfinger		 source 5
PharmaSUG 2012 Creating the Time to Event ADaM Dataset: The Nuts and Bolts Nancy Brucken,
Paul K. Slagle		 source 7
PharmaSUG 2012 Gilding the Lily: Boutique Programming in TAGSETS.RTF Rohini Rao,
Paul D. Hamilton		 source 9
SESUG 2011 Resolving OpenCDISC Error Messages Using SAS John R. Gerlach source 11
WUSS 2011 Analyze This? Supporting Clinical Decisions Graphically When Not Enough Data is Available A Study Case: Challenges in NCI CTCAE Version 4 Grading Sheila Dayog source 4
NESUG 2011 Product Repository: Oblectives and Utilization - A Case Study Amit Bhanose,
Smitha Mullapudi		 5
PharmaSUG 2011 Creating Customized Patient Profiles using SAS ODS RTF and PROC TEMPLATE Andrea Ritter source 10
PharmaSUG 2011 Creating Hyperlinked PDF Graphical Patient Profiles with PROC REPORT William Conover source 11
PharmaSUG 2011 From SAP to BDS: The Nuts and Bolts Nancy Brucken,
Paul K. Slagle		 source 9
PharmaSUG 2011 Macro to Generate Summary and Descriptive Statistics Tables Yogesh Pande source 6
PharmaSUG 2011 Validating Controlled Terminology in SDTM Domains John R. Gerlach source 12
SGF 2011 Healthcare Intelligence: The Challenge of OLAP for Healthcare Data John Leveille source 10
PHUSE EU 2010 Interactive Clinical Data Review for Safety Assesment and Trial Operations Management Michael O'Connell source
presentation source		 13
PHUSE EU 2010 PROC TRANSPOSE for Better Listings View Jules Van der Zalm source 8
PHUSE EU 2010 Statistical Graphics for Review and Reporting in Clinical Development Kerstin Pietzko,
Michael O'Connell		 source
poster source		 12
PHUSE EU 2010 The Ultimate Integration Challenge Jennifer Choon-Moi Chin,
Hester Schoeman		 source
presentation source		 11
PharmaSUG 2010 CDASH Standards for Medical Device Trials: CRF Analysis Parag Shiralkar,
Jennie Tedrow,
Kit Howard,
Laura Fazio,
Daniela Luzi,
Rhonda Facile		 8
PharmaSUG 2010 Create Comprehensive Patient Profiles with SAS Sanjay N. Matange,
Daniel O'Connor		 12
PharmaSUG 2010 From SAP to ADaM: The Nuts and Bolts Nancy Brucken,
Paul K. Slagle		 9
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
SGF 2010 Establishing Consistent Programming for Pharmaceutical Safety Summarizations Using a DOW Loop Bradford J. Danner,
Steven R. Kirby		 source 8
PHUSE EU 2009 Kendle Implementation of CDASH [presentation] Elke Sennewald,
Gill Lawrence		 source 32
PHUSE EU 2009 PROC TRANSPOSE for Better Listing View Jules Van der Zalm source 8
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
PHUSE EU 2009 The Perfect Match - an appreciation of the functionality of the dataset MERGE Diana Stuart source 5
NESUG 2009 A Taste of SDTM in Real Time Changhong Shi,
Beilei Xu		 6
PharmaSUG 2009 A SAS Macro Application for Generating Patient-Level Reports in Clinical Studies Yao Huang 4
PharmaSUG 2009 Establishing Consistent Programming for Pharmaceutical Safety Summarizations Using a DOW Loop Bradford J. Danner,
Steven R. Kirby		 8
PharmaSUG 2009 Generic System for Generating Data Listings Cheng Jun Tian 15
PHUSE EU 2007 LSLV to Final CSR Tables in 24 hours - Dream or Reality? Stinder Fowler source 10
PHUSE EU 2007 Runtime funtime: Vertical data reporting using runtime formats Michael Auld source 11
PHUSE EU 2007 Web techniques for SAS ODS output and more Jules Van der Zalm source 8
PharmaSUG 2007 The Creation of Time Deviations Karen Easterling 5
PharmaSUG 2007 The TRANPOSE Procedure or How to Turn It Around Janet E. Stuelpner 9
PHUSE EU 2006 Statistical Graphics and Reporting in Drug Development Michael O'Connell,
Sven Knudsen		 source 13
SUGI 2006 The TRANSPOSE Procedure or How to Turn It Around Janet E. Stuelpner source 9
SESUG 2005 Proc Transpose or How to Turn It Around Janet E. Stuelpner source 7
PHUSE EU 2005 The Dataset Diet - How to transform short and fat into long and thin Kathryn Wright source 6
PharmaSUG 2005 Programming and Data Differences Between Clinical Trials and Observational Studies Margaret M. Coughlin 6
PharmaSUG 2005 Strategies for Implementing SDTM and ADaM Standards Susan J. Kenny,
Michael A. Litzsinger		 8
PharmaSUG 2005 The Role of Analysis Datasets in Successful FDA Advisory Meetings Sandy Chang 9
PharmaSUG 2005 Using V9 ODS LAYOUT to Simplify Generation of Individual Case Summaries Ling Y. Chen 8
NESUG 2004 Clinical Trials Online - Running SAS on the Web Without SAS/IntrNet Quan Ren 15
WUSS 2004 Successful FDA Advisory Meetings by using Analysis Datasets Sandy Chang,
Steven Wong		 source 10
SUGI 2004 Clinical Trial Online - Running SAS on the Web without SAS/IntrNet Quan Ren source 16
SUGI 2004 Widefiles, Deepfiles, and the Fine Art of Macro Avoidance Howard L. Kaplan source 11
WUSS 2003 Discovering a New Human Vital Sign August L. Stemmer source 5
NESUG 2002 Clinical Trial Online - Running SAS on the Web without SAS/IntrNet Quan Ren 7
PharmaSUG 2002 Clinical Trial Online - Running SAS on the Web without SAS/IntrNet Quan Ren 8
SUGI 2002 Clinical Trial Online - Running SAS on the Web without SAS/IntrNet Quan Ren source 7
SUGI 2002 Dynamic Data Matching in Clinical Trial Research Zaizai Lu,
David Shen		 source 4
PharmaSUG 2001 Data Visualization of Phase 1 Clinical Studies - "Big Al's World" or Using SAS Version 8 to Acquire Quality Ice Cream Richard F. Synowiec 8
SUGI 2001 Clinical Trial System - A Front End SAS/AF Application Quan Ren source 7
SUGI 2001 Data Visualization of Phase 1 Clinical Studies - by "Big Al's Worlds " Richard F. Synowiec source 6
PharmaSUG 2000 Using SAS Macro to Create Data Driven Format Statement for Clinical Data Flagging Pilita Canete,
Melanie A. Paules,
Shi-Tao Yeh		 5
SESUG 1998 Programmatic Generation of Table Specifications Using the SAS Macro Facility Weimin "WilHam" Sun,
Caroline Stewart		 10
SCSUG 1997 A Macro to Account for Missing Data in a Table Margie Bell,
Stephen Black,
Jennifer K. Fulton		 10
WUSS 1997 Desing of the Clinical Data Portion of a CANDA to Facilitate Review by CDER Kay Obenshain source 5
PharmaSUG 1997 Design of the Clinical Data Portion of a CANDA to Facilitate Review by CDER Kay Obenshain 5
SUGI 1997 Validation and SAS Programming: Benefits of Using the System Life Cycle Method Russell Newhouse source 5
NESUG 1995 The Adoption of Computer Interface Technologies in Health Services Delivery Richard Switalski 9
WUSS 1995 Designing an Integrated Safety Summary of Clinical Trials Linda Collins,
Patricia L. Gerend		 source 6
NESUG 1994 Validating Your SAS Program Jennifer Dougherty 4
SUGI 1993 BLOOD PRESSURE AND HEART RATE vs TIME Lan Tran-La source 8
SUGI 1988 Graphical Presentation of Clinical Data Using SAS Macros Pan-Yu Lai,
Thomas E. Schneider		 source 4
SUGI 1988 Use of the SAS System, CMS REXX, and ISPF to Generate Standardized Vital Signs Reports for Clinical Studies Rong Q. Pan source 6

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