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156 papers and 15 presentations; 156 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG CN 2026 DualBookmarker: A Python Tool to Create Dual Bookmarks for Annotated CRF Xianhua Zeng source 4
PharmaSUG 2026 Smarter, Faster, Better: GenAI-Driven Authoring for Data Reviewer's Guides Christina Scienski,
Christine Rossin		 source 4
PHUSE US 2026 Enhancing Clinical Study Processes Through AI-Driven Documentation Automation Pinku Hooda source
presentation source		 3
PHUSE US 2026 Not Another Other: Bridging Data Collection with SDTM Mapping Without Open Text Fields Aminta Jimenez source
presentation source		 6
PHUSE US 2026 Opening Session - Global Data Sharing Platforms: Aligning Frameworks, Pressures and Opportunities [presentation] Cathal Gallagher source 31
PHUSE US 2026 Semi-automating Case Report Form Annotations Using Python and a Metadata Repository Alvin Mathew source
presentation source		 8
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
SESUG 2025 Statistical Programmer's role in Bioresearch Monitoring (BIMO) package creation Sampath Madanu 25
PharmaSUG 2025 Checking SDTM Datasets from Biostatistical Perspective Inka Leprince,
Elizabeth Li		 source 14
PharmaSUG 2025 Streamlining BIMO and Patient Profile Generation: A Python-Based Semi-Automated Approach Integrated with CSR Development Dmytro Skorba,
Mykyta Vysotskyi		 source 15
PHUSE US 2025 Automating SDTM Annotated CRF (aCRF) Creation David Postma,
Christine Rossin		 source
presentation source		 6
PHUSE US 2025 How Unique is it for the Subject Identifier in a Study To Have Multiple Screenings and Enrolments? Anahita Vyas,
Rama Kudaravalli		 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 EU 2024 Auto-Generating the List of Tables from a Statistical Analysis Plan - A Case Study [presentation] Jaya Simha Inampudi,
Krishna Gopal		 source 14
PHUSE EU 2024 Leveraging the USDM Standard in OpenStudyBuilder for Enhanced Data Exchange Marius Conjeaud source
presentation source		 7
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
WUSS 2024 Will statistical programmers be replaced by Artificial Intelligence? [presentation] Junying Zhang source 20
PharmaSUG CN 2024 Extracting Useful Information from XFDF Format of aCRF Annotations Tingting Zhang,
Yuan Sun		 source 13
PharmaSUG 2024 Advancing the Maturation of Standardized CRF Design Sugumaran Muthuraj,
Rubha Raghu		 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
PHUSE US 2024 Revolutionising SDTM Transformation in Pharma: Introducing {oak} - An Open-Source R Package Sponsored by CDISC COSA Rammprasad Ganapathy source
presentation source		 5
PHUSE EU 2023 A new standard of excellence; introducing the annotated Screen Report Franklin E. Menius source
presentation source		 8
PHUSE EU 2023 Open-Source MDR and SDR - Managing Your Standards with the OpenStudyBuilder Nicolas De Saint Jorre,
Mikkel Traun		 source
presentation source		 13
PHUSE EU 2023 Open-Source Protocol Automation with the OpenStudyBuilder Nicolas De Saint Jorre,
Mikkel Traun		 source
presentation source		 9
PHUSE EU 2023 SDTM CRT Packages and the Submission Space Joshua Glaser,
Charlotte Prior-Chappell		 source
poster source		 7
PHUSE EU 2023 Standardisation in a fast growing environment; MDR, EDC and other abbreviations Louella Schoemacher,
Jasmine Kestemont		 source
presentation source		 6
PharmaSUG 2023 As Simple as Falling Off a Log?: An Unusual Case Study of Mapping Data into the SDTM DA (Drug Accountability) Domain Susan Mutter source 9
PharmaSUG 2023 Gear up the Metadata - Automating Patient Profile Generation, a Metadata Driven Programming Approach Tanmay Khole,
Aman Sharma,
Lili Li,
Durga Prasad Chinthapalli		 source 20
PharmaSUG 2023 Handling of Vaccine SDTM Data for FDA CBER/OVRR Submission Compliance Pragathi Mudundi,
Zhaoyu Xie		 source 5
PHUSE US 2023 Implementation of Estimands (ICH E9 (R1)) Using Data Standards [presentation] Banoo Madhanagopal,
Lori Van Meter		 source
video		 32
PHUSE US 2023 Master Protocol Design: Advantages and Challenges in Vaccine Clinical Trials [presentation] Janaki Shankaran,
Meenal Gawas		 source
video		 19
PHUSE EU 2022 Bioresearch Monitoring Data Reviewer's Guide (BDRG) [presentation] Jack Field,
Steve Fitzpatrick		 source
video		 20
WUSS 2022 Cautionary Notes when Working with Interim Data Bill Coar source 8
PHUSE US 2022 A Better Way: eCOA/ePRO Annotated Screen Reports (aSR) Provide Data Clarity from Data Collection to Submission Franklin E. Menius,
Monali Khanna,
Vincent Allibone		 source
presentation source		 6
PHUSE US 2022 The Bioresearch Monitoring Data Reviewer's Guide (BDRG) [presentation] Julie Maynard,
Sopan Dharma Kaith		 source 25
PHUSE EU 2021 New Starters Session: The Secret Sauce to Start in Our Industry [presentation] Amritpal Singh,
Lucie Bowden		 source 10
PHUSE EU 2021 The Library Approach Driving EDC Set-up Efficiencies: A Case Study [presentation] Jan De Cleir source
video		 23
PHUSE US 2021 Good Cooperation Between SAS and R for Regulatory Submission [presentation] Jingyuan Chen source
video		 19
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 Easing the Process of Creating CRF Annotations Samadi Karunasundera,
Jun Wang		 source 7
PharmaSUG 2020 A Novel Solution for Converting Case Report Form Data to SDTM using Configurable Transformations Sara Shoemaker,
Matthew Martin,
Robert Kleemann,
David Costanzo,
Tobin Stelling		 source 12
PharmaSUG 2020 An Effective Management Approach for a First-Time Study Lead Himanshu Patel,
Jeff Xia		 source 10
PharmaSUG 2020 Automating CRF Annotations using Python Hema Muthukumar,
Kobie O'Brian,
Julie Stofel		 source 9
PharmaSUG 2020 Moving A Hybrid Organization Towards CDISC Standardization Kobie O'Brian,
Sara Shoemaker,
Robert Kleemann,
Kate Ostbye		 source 8
PHUSE US 2020 A Journey Through End to End Data Flow Marcin Makowski,
Stayce Murray		 source
presentation source		 12
PHUSE US 2020 A Programmer's Journey through the BIMO Submission Process Raghavender Ranga source
presentation source		 12
PHUSE US 2020 Adverse Event and Treatment Emergent Approaches in the Industry Aimee Basile source
poster source		 11
PHUSE US 2020 CDISC 360: Using Biomedical Concept Metadata to Generate Case Report Forms and Dataset Definitions Samuel Hume source
presentation source		 13
PHUSE US 2020 Poster - PP23 Mike Tan,
Richard Addy,
Deidre Kreifels		 source
poster source		 9
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
PharmaSUG 2019 The Anatomy of Clinical Trials Data: A Beginner's Guide Venky Chakravarthy source 14
PHUSE US 2019 High-quality Study Data Standards for Submission Majdoub Haloui,
Ellen L. Asam		 source
presentation source		 9
PHUSE US 2019 Utilizing Artificial Intelligence for Efficient CRF Design Komal Govil,
Sai Vundela		 source
presentation source		 5
PHUSE US 2019 What Does Good Look Like in the Study Data Standardization Plan (SDSP)? Pritesh Solanki,
Janet Low		 source
presentation source		 5
PHUSE EU 2018 How Machine Learning Can Automate Data Standardization in Clinical Trials [presentation] Fanyi Zhang source 16
PHUSE EU 2018 Stop Copying CDISC Standards Craig Parry source
poster source		 21
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 Report Compatibility: System to evaluate your code against volatile sources. Joseph Cooney,
Randy Santiano,
Craig Brelage		 source 12
PharmaSUG 2018 Standardization Efforts at Medtronic, its benefits and Lessons Learned Firdouse Fathima source 4
SGF 2018 The Anatomy of Clinical Trials Data: A Beginner's Guide Venky Chakravarthy source 14
PHUSE EU 2017 CDISC Transport Standards - A Glance Edwin Ponraj Thangarajan,
Giri Balasubramanian		 source
presentation source		 14
PHUSE EU 2017 End-to-End Traceability from Protocol Development to Submission Mikkel Traun,
Trine Danø Klingberg		 source
presentation source		 3
PharmaSUG 2017 Harmonizing CDISC Data Standards across Companies: A Practical Overview with Examples Keith Shusterman,
Prathima Surabhi,
Binoy Varghese		 source 6
PharmaSUG 2017 SAS Application to Automate a Comprehensive Review of DEFINE and All of its Components Walter H. Hufford Jr.,
Vincent Guo,
Mijun Hu		 source 8
WUSS 2016 SDTM Bookmarking Automation: Leveraging SAS, Ghostscript and Form-Visit Study Data Nasser Al Ali,
Maria Paz		 source 6
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 Have SAS Annotate Your Blank CRF for You! Plus Dynamically Add Color and Style to Your Annotations Steven C. Black source
zip		 16
PHUSE EU 2015 CDISC Standards and the Semantic Web David Iberson-Hurst source
presentation source		 9
PHUSE EU 2015 CONNECT and CREATE - Connect Standards and Enable Protocol Authoring Abi Velurethu,
Susanne Pangritz		 source
presentation source		 16
PHUSE EU 2015 Developing annotated CRF: SAS, Excel and patience as your friends Ilias Pyrnokokis source
presentation source		 8
PharmaSUG CN 2015 Automatic generating blankcrf.pdf for Rave Study Haiqiang Luo 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
SESUG 2014 Stretching Data Training Methods: A Case Study in Expanding SDTM Skills Richard Addy source 4
PHUSE EU 2014 Automating Production of the blankcrf.pdf Walter H. Hufford Jr. source
presentation source		 5
PHUSE EU 2014 Findings About: "Findings About" Madhura Khare source
presentation source		 8
PHUSE EU 2014 Transparency in the Time of Constant Change Todd Case source
presentation source		 4
PharmaSUG CN 2014 An implementation of XSL-FO techniques to convert define.pdf from define.xml Kyle Chang 6
PharmaSUG 2014 A SAS Macro to address PK timing variables issues Timothy J. Harrington source 14
PharmaSUG 2014 Automating Production of the blankcrf.pdf Walter H. Hufford Jr. source 5
PharmaSUG 2014 Creating Define-XML version 2 with the SAS Clinical Standards Toolkit 1.6 Lex Jansen source 33
PharmaSUG 2014 How Valued is Value Level Metadata? Shelley Dunn source 12
PharmaSUG 2014 QC made easy using macros Prashanthi Selvakumar source 7
PHUSE EU 2013 Define-XML v2 - What's New Lex Jansen source
presentation source		 15
PHUSE EU 2013 Visual Approaches for Safety Analysis and Review of Clinical Trials [presentation] Valérie Nedbal source 34
NESUG 2013 Use of SAS for Clinical Trial Management and Risk-Based Monitoring of Multicenter Clinical Trial Data from Electronic Data Capture Tools Bob Hall,
David Gagnon		 14
PharmaSUG 2013 A Quick Patient Profile: Combining External Data with EDC-generated Subject CRF Titania Dumas-Roberson,
Yang Han		 source 5
PharmaSUG 2013 Good vs Better SDTM: Limitations as Operational Model Henry B. Winsor,
Mario Widel		 source 4
NESUG 2012 A Visual Approach to Monitoring Case Report Form Submission During Clinical Trials Rebecca Horney,
Karen Jones,
Annette Wiseman		 7
SESUG 2012 A Visual Approach to Monitoring Case Report Form Submission During Clinical Trials Rebecca Horney,
Perry Point		 source 7
PharmaSUG 2012 Metadata: Some Fundamental Truths Frank C. DiIorio source 10
PharmaSUG 2012 Using the SAS Clinical Standards Toolkit 1.4 for define.xml creation Lex Jansen source 30
MWSUG 2011 I Don't Look Good in Orange or Stripes Susan M. Fehrer 4
NESUG 2011 Metadata: Some Fundamental Truths Frank C. DiIorio 9
PharmaSUG 2011 Creating a define.xml file for ADaM and SDTM John H. Adams source 18
SGF 2011 Using SAS to Incorporate the SDTM for a Study Funded by the NIH Fenghsiu Su,
Bradford Jackson,
Kaming Lo,
Sumihiro Suzuki,
Karan Singh,
David Coultas		 source 8
PHUSE EU 2010 Define.xml - Tips and Techniques for Creating CRT-DDS Julie A. Maddox,
Mark Lambrecht		 source
presentation source		 10
PHUSE EU 2010 How Do I Map That? - SDTM Implementation Challenges Chris Price source
presentation source		 11
SESUG 2010 Proc Report Data = Subject.Event_Chronology; Christina Carty,
Elizabeth R. Spence		 source 12
PharmaSUG 2010 Accessing and using the metadata from the define.xml [presentation] Lex Jansen 74
PharmaSUG 2010 Accessing the metadata from the define.xml using XSLT transformations Lex Jansen 70
PharmaSUG 2010 Creating SV and Se First Henry B. Winsor,
Mario Widel		 7
PharmaSUG 2010 Quality in a World of "Standards" with Differences! Sandra VanPelt Nguyen 9
PHUSE EU 2009 CRT for eCTD submission Aurelien Guillouche source
presentation source		 8
WUSS 2009 BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users Clinton Brownley source 6
PharmaSUG 2009 Converting the define.xml to a Relational Database to Enable Printing and Validation [presentation] Lex Jansen 76
PHUSE EU 2008 How big? Oh my...it's time to prepare! Julie Oates source 4
PHUSE EU 2008 Using the SAS XML Mapper and ODS to create a PDF representation of the define.xml Lex Jansen source 21
NESUG 2008 Clinical-Data Acceptance Testing Procedure Sunil Kumar Gupta 15
NESUG 2008 Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed) Lex Jansen presentation 20
PharmaSUG 2008 Clinical-Data Acceptance Testing Procedure Sunil Kumar Gupta 15
PharmaSUG 2008 Using the SAS XML Mapper and ODS PDF to create a PDF representation of the define.xml (that can be printed) Lex Jansen 20
SGF 2008 Clinical-Data Acceptance Testing Procedure Sunil Kumar Gupta source 15
NESUG 2007 Presentation and Handling of Clinical Laboratory Data -- From Test Tube to Table Randall Carlson,
Nate Freimark		 13
PHUSE EU 2007 Electronic submissions - the role of the programmer Simon Dundas source 8
PharmaSUG 2007 Can Coding MedDRA and WHO Drug Be as Easy as a Google Search? Sy J. Truong 9
SGF 2007 Can Coding MedDRA and WHO Drug Be as Easy as a Google Search? Sy J. Li,
Na Truong		 source 9
SESUG 2006 The Absolute Nitty-griddy of ODS Layout: Part I Annette I. Ladan source 9
WUSS 2006 An Approach Finding the Right Tolerance Level for Clinical Data Acceptance Karen Walker source 5
WUSS 2006 New CDISC Training Initiative Dana Rafiee source 2
NESUG 2006 It's About Time! A Primer on Time-Slotting of Data Using SAS Maria Y. Reiss 13
PharmaSUG 2006 CDISC Submission and Compliance Training, The New Virtual Learning Methodology Dana Rafiee,
Michael C. Palmer		 2
WUSS 2005 Data Integrity through DEFINE.PDF and DEFINE.XML Sy J. Truong source 14
PharmaSUG 2005 How is Outsourcing Going to Affect SAS Programming? Thu-Thuy Truong,
Sy J. Truong		 7
PharmaSUG 2005 Utility Macros Used in the Process for Database Translations Yuguang Zhao,
Jingchun Yu		 3
PharmaSUG 2004 Automation of Patient Narratives Using SAS and Analysis Datasets David C. Izard 6
PharmaSUG 2004 Clinical Trials Terminology for SAS Programmers Sy J. Truong 6
SCSUG 2003 Data Management, Statistics and Dog Bones??? O. M. Little 6
PharmaSUG 2003 Cross-referencing Data Contents and Case Report Form Sam Mao 4
PharmaSUG 2003 Testing CDISC's Operational Data Model in SAS Michael C. Palmer 4
PharmaSUG 2002 An Automation System for Generating Case Report Form Tabulations David C. Izard,
Shi-Tao Yeh		 6
PharmaSUG 2002 Using SAS to get more out of Oracle Clinical Jim Johnson 10
SEUGI 2000 Creating PDF Documents including hyper-links, bookmarks and a table of contents with the SAS Software [presentation] Lex Jansen source 39
PharmaSUG 2000 GLOBAL INTEGRATED DATABASE (GIDB): Not Just a SET Statement Marla A. Childers 4
SESUG 1999 Using SAS/AF to Create Applications for the Administrative Aspects of Data Management in Clinical Trials Emily A. Mixon,
Karen B. Fowler,
Felicita David		 source 4
SESUG 1998 Building Clinical Information Spaces on the World Wide Web Paul C. Wehr 4
PharmaSUG 1998 Building Clinical Information Spaces on the World Wide Web Paul C. Wehr 4
SUGI 1998 Building Clinical Information Spaces on the World Wide Web Paul C. Wehr source 4
SESUG 1997 Developing an Executive Information System with SAS/EIS Software Matthew J. Becker 6
PharmaSUG 1997 ClinAccess: An Integrated Client/Server Approach to Clinical Data Management and Regulatory Approval Martin J. Rosenberg 9
PharmaSUG 1997 How Do I Take the Mean of an Apple and an Orange? Techniques for Integrating Data from Multiple Studies Linda Collins 8
PharmaSUG 1997 Software Validation for the Rest of Us Michael C. Harris 9
NESUG 1996 Simplifying Case Report Form Automation: An Example Application Using SAS, ODBC, OLE, and Visual Basic Michael Tomb,
Jeffrey D. Hart		 4
WUSS 1996 ClinAccess: An Integrated Client/Server Approach to Clinical Data Management and Regulatory Approval Martin J. Rosenberg source 9
PNWSUG 1996 ClinAccess: An Integrated Client/Server Approach to Clinical Data Management and Regulatory Approval Martin J. Rosenberg 9
SEUGI 1996 Re-engineering the CAPLA: integrating electronic submissions into the drug development Guy Pawson source 34
SUGI 1996 ClinAccess: An Integrated Client/Server Approach to Clinical Data Management and Regulatory Approval Martin J. Rosenberg source 9
WUSS 1995 ClinAccess: An Integrated Client/Server Approach to Clinical Data Management and Regulatory Approval Martin J. Rosenberg source 9
SUGI 1995 ClinAccess: A Client/Server Approach to Clinical Trials Data Management and Regulatory Approval Martin J. Rosenberg source 7
SEUGI 1994 A Frame-based Case Report Form Tracking System Sue Copping source 6
SEUGI 1994 Files and Frames Sue Copping source 6
SUGI 1994 Developing Integrated Clinical Trials Systems: The ClinAccess Experience Martin J. Rosenberg source 7
NESUG 1993 Data Entry of Text Strings: SAS/AF Extended Tables vs SAS/FSP Scott Rompala 5
NESUG 1993 Optimization of Adverse Event Auto-Encoding Walter R. Young 5
WUSS 1993 An Integrated Clinical Trials System Utilizing Client Server and Graphical User Interface Technology Martin J. Rosenberg source 7
MWSUG 1993 Using SAS to Create Statistical CANDA (SCANDA) Datasets Rocco L. Brunelle,
Debbie Romjue-Bailey,
Bill Huster,
Michelle McNabb,
Sharon Symanowski,
Ted Shaw,
Linda Bergin,
Kathy Koskowicz		 5
SUGI 1993 An Integrated Clinical Trials System Utilizing Client Server and Graphical User Interface Technology Martin J. Rosenberg source 7
SESUG 1993 Some Thoughts on Making DSGI User-Friendly Jim Comer 9
SUGI 1992 An Integrated Clinical Information System for Pharmaceutical Research Martin J. Rosenberg source 7
SUGI 1991 A Clinical Data Review System to Facilitate Pharmaceutical Research Martin J. Rosenberg source 9
SUGI 1991 Database Validation: A Random-Sample Audit Procedure Bruce Wentworth,
James M. Harper,
Barbara A. Costantini,
David A. Bennett		 source 4
NESUG 1989 The CIVE Program: A Quality Assurance Program for Clinical Study Data Joyce Bartner 8
SUGI 1988 Integration of ORACLE and the SAS System in the Generation of Adverse Experience Reports Chih-Wu Chang,
Edward F.C. Pun		 source 5
SUGI 1988 Using the SAS System to Facilitate Clinical Trials Research and NDA Approval Martin J. Rosenberg source 7
SUGI 1986 A Computerized System for the Preparation of Data Entry Instructions Ruth F. Quah source 5
SUGI 1986 A SAS Based System for Calculating and Tracking Data Processing Error Rate Estimates Ellen Gilkerson,
Virginia Ozer		 source 4
SUGI 1986 SAS Software and the IBM Dialog Manager Chris E. Corcoran source 6
SUGI 1985 A SAS-based LOG System for Keeping Track of Computerized Clinical Trial Data Ruth F. Quah source 4
SUGI 1984 CPDMS-A Clinical Pharmacology Data Management System Rita Brilla,
Lorna Lyall,
Lois Preis		 source 7
SUGI 1984 THECIS-The Clinical Information System Judith A. Burns,
Leon T. Hairie,
Thomas R. Hoffman		 source 6
SUGI 1983 Adverse Reaction Incidence Tables for Clinical Trials Donna R. Park,
Stephen J. Ruberg		 source 5
SUGI 1981 Automated Management of the Regulatory Aspects of the Development and Registration of Pharmaceutical Products F. A. Adornato,
D. K. Jackson,
R. A. Michalak,
C. A. Simon,
C. S. Snoddy		 source 3

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