| PharmaSUG |
2026 |
Beyond Today-s Evidence: How AI-Enabled RWE Will Transform Development Speed, Study Quality, and Real-World Impact |
Sherrine Eid |
source |
15 |
| PHUSE US |
2026 |
Harnessing AI: Enhancing Test Data Quality and Efficiency in Clinical Trial Set-Up |
Rita Pecuch,
Varun Jagadeesh |
source
poster source |
8 |
| 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 |
What Pharma Can Learn from Data Science Outside the Industry |
Kris Wenzel,
Liz Cole |
source
presentation source |
11 |
| PHUSE EU |
2025 |
Enabling Standardised Data Collection Through Governance Processes and Automation [presentation] |
Clara Giménez Arteaga,
Christine Mathiesen |
source |
17 |
| 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 |
Preserving the Blind: Cross-Functional Solutions During Study Design Evolution from Blinded Parent to Open-Label Extension |
Tanmay Khole |
|
5 |
| PharmaSUG |
2025 |
A collaborative and agile approach for end to end Standards Governance and Release |
Kairav Tarmaster,
Pratiksha Wani |
source |
10 |
| PharmaSUG |
2025 |
Efficient CDISC Controlled Terminology Mapping: An R-Based Automation Solution |
Yunsheng Wang |
source |
8 |
| PharmaSUG |
2025 |
Improve Your CRF Review Process: A Python-Based Approach to Capturing CRFs via Browser Automation |
Andrew Herndon |
source |
8 |
| PharmaSUG |
2025 |
Use Gen AI to program rules in R & Python to generate and validate metadata for data standards and study specifications. |
Priyanka Sawant,
Kairav Tarmaster |
source |
9 |
| PharmaSUG |
2025 |
{sdtm.oak} V0.1 on CRAN, sponsored by CDISC COSA, part of Pharmaverse, is an EDC and Data Standard agnostic solution for developing SDTM datasets in R. |
Rammprasad Ganapathy |
source |
5 |
| PHUSE US |
2025 |
eProtocol and the Promise of Automation |
Bill Qubeck,
Suhas Giriraj |
source
presentation source |
17 |
| 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 Custom GPT to Write Edit Checks |
Andrew Burd |
source
presentation source |
3 |
| PHUSE US |
2025 |
{sdtm.oak} - SDTM Programming in R |
Rammprasad Ganapathy,
Shiyu Chen |
source
poster source |
5 |
| PHUSE EU |
2024 |
AI Got the Power: Streamlining Clinical Data Creation |
Emily Yates,
Matt Luppino,
Andrew Burd |
source
presentation source |
12 |
| PHUSE EU |
2024 |
Enhancing Quality of External Data |
Pascale Youinou |
source
presentation source |
6 |
| PHUSE EU |
2024 |
Where Does Your SCE Fit in Your Data Strategy? |
Phil Loucks |
source
presentation source |
7 |
| PharmaSUG CN |
2024 |
A metadata-driven system to generate annotated CRF automatically |
Guojun Liufu,
Jun Wu,
Li Chen,
Zhen Peng,
Fushan Lai,
Hanjia Zheng |
source |
7 |
| PharmaSUG CN |
2024 |
The Imperative Role of Data Cut-Off (DCO) in Clinical Trials: Ensuring Integrity and Precision in Oncology |
Nana Yang,
Chunpeng CZ Zhao |
source |
6 |
| 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 |
Externally Yours - Adeptly Managing Data Outside Your EDC System |
Frank Canale |
source |
38 |
| PharmaSUG |
2024 |
Protocol Amendments and EDC Updates: Downstream impact on Clinical Trial Data |
Anbu Damodaran,
Ram Gudavalli,
Kumar Bhimavarapu |
source |
11 |
| PHUSE US |
2024 |
Front-Loading Statistical Programming Using Automated Synthetic Data |
Faezeh Moshfeghifar,
Hemanth Padmakar |
source
presentation source |
5 |
| 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 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 Robust Framework to Provide and Validate Real-Time SDTM Data |
Bremer Louw |
source
presentation source |
11 |
| PHUSE EU |
2023 |
Data Managers and R Programming: The Unlikely Pair |
Anaelle Perretti (Bonetta) |
source
presentation source |
9 |
| PHUSE US |
2023 |
Investigator Initiated Trials: Turbulence ahead! |
Helen Liu,
Vineet Mathur |
source
presentation source |
3 |
| PHUSE EU |
2022 |
iCDM: Interactive Dashboards that Innovate Centralised Clinical Data Monitoring at Danone Nutricia Research |
Paul Vervuren,
Dennis Menkveld |
source
video
presentation source |
5 |
| PHUSE EU |
2022 |
RBM Beyond the Mandate: The Importance and Impacts of Risk-based Monitoring Today [presentation] |
Gina Wood,
Alison Banda |
source |
14 |
| WUSS |
2022 |
Quick Jumpstart into Pharmaceutical SAS Programming |
Jim Box,
Matthew J. Becker |
source |
7 |
| PharmaSUG |
2022 |
Automation using SAS Makes it Easy to Monitor Dynamic Data in Clinical Trial |
Wenjun He |
source |
9 |
| PHUSE EU |
2021 |
Next Generation MDR Solution for Study Design and Configuration Using Concept-based Standards [presentation] |
Mikkel Traun |
source
video |
15 |
| PHUSE EU |
2021 |
Real-world Data, CDISC SDTM, HL7 FHIR and the Future of Regulatory Submissions [presentation] |
Jozef Aerts |
source
video |
17 |
| PHUSE EU |
2021 |
Standard Implementation: Battling Through the Adversity of a Pandemic [presentation] |
Ana Arques,
Vicky Poulsen |
source
video |
18 |
| PHUSE US |
2021 |
An R-based Tool to Build Questionnaires, Ratings and Scales (QRS) in EDC for Clinical Trials [presentation] |
Catherine Abogado,
Rammprasad Ganapathy |
source
video |
19 |
| PHUSE US |
2021 |
The Case for Pandemic-disrupted Studies and Challenges Implementing CDISC and FDA COVID-19 Guidelines for NDA Submissions [presentation] |
Vidya Muthukumar |
source |
44 |
| SGF |
2021 |
An Integrated-Software Solution for Automated and Reliable Distributed Reporting System |
Noga Meiry Lewin,
Aimee Wahle,
Amarnath Vijayarangan,
Abigail G. Matthews |
source |
11 |
| PHUSE EU |
2020 |
Advancing SDTM Annotation Through Automation [presentation] |
Anja Kreis,
Wolfgang Rohnert |
source
video |
20 |
| SESUG |
2020 |
Learning from Experience Requires a Collaborative Team Effort: an Integrated-Software Solution for Automated and Reliable Distributed Reporting System |
Noga Meiry Lewin,
Amarnath Vijayarangan |
source |
11 |
| PHUSE US |
2020 |
A Journey Through End to End Data Flow |
Marcin Makowski,
Stayce Murray |
source
presentation source |
12 |
| PHUSE EU |
2019 |
Educating for the Future: Data Engineering Techniques |
Guy R. Garrett |
source
presentation source |
10 |
| PHUSE EU |
2019 |
Formedix On: Advanced Metadata Management and Data Conversion [presentation] |
Kevin Burges |
source |
47 |
| SGF |
2019 |
Statistical Data Checks to Identify Questionable and Suspicious Data |
Kaitie Lawson |
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 |
Voice-based Clinical Monitoring Assistant |
Anoop Ambika |
source
presentation source |
7 |
| PHUSE EU |
2018 |
Bridging the Visual Analytics-EDC Gap to Accelerate Centralised Data Monitoring |
Luis Torres |
source
presentation source |
4 |
| PHUSE EU |
2018 |
Data Visualisation in a Risk-Based Approach to Support Decision-making |
Joke De Wever,
Irina Sargsyan |
source
presentation source |
12 |
| PHUSE EU |
2018 |
eSource to SDTM: Trade-offs and Pay-offs |
Donald Benoot,
Swapna Pothula |
source
presentation source |
11 |
| PHUSE EU |
2018 |
Handling CRF Design Changes in a Live Environment |
Andre Snelting,
Nieke De Ruiter |
source
presentation source |
10 |
| 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 |
| PHUSE US |
2018 |
Implementing an Metadata Repository Solution - A User Story |
Barrie Nelson,
Wade Fairbanks |
source
presentation source |
5 |
| PHUSE US |
2018 |
Supporting a Data Review and Visualization Application with SDTM |
Deepika Sunkara,
Jagadish Dhanraj |
source
presentation source |
6 |
| PHUSE US |
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 |
| PharmaSUG |
2018 |
Combining Electronic Diary Seizure Data with Visit-Based Seizure Data in the MONEAD Study |
Ryan May,
Julia Skinner |
source |
8 |
| PharmaSUG |
2018 |
Let's get to the Source and streamline it to the End |
Jennifer Price |
source |
6 |
| PHUSE EU |
2017 |
Devices Big Data and Real World Evidence |
Mike Collinson |
source
presentation source |
7 |
| PHUSE EU |
2017 |
Formedix On: A Powerful Platform to Accelerate Clinical Trials |
Kevin Burges |
source
presentation source |
2 |
| PHUSE EU |
2017 |
How a Metadata Repository can Facilitate Automated Data Collection Processes |
Judith Goud |
source
presentation source |
8 |
| PHUSE EU |
2017 |
SDTM vs CDASH: Why You Need Them Both! [presentation] |
Kit Howard,
Shannon Labout |
source |
20 |
| PharmaSUG |
2017 |
Leveraging Study Data Reviewer-s Guide (SDRG) in Building FDA-s Confidence in Sponsor-s Submitted Datasets |
Xiangchen (Bob) Cui,
Min Chen,
Letan (Cleo) Lin |
source |
10 |
| PharmaSUG |
2017 |
Real Time Clinical Trial Oversight with SAS |
Ashok Gunuganti |
source |
7 |
| PHUSE EU |
2016 |
Challenges and Opportunities with the Implementation of a Single-instance Cloud Research Platform |
Doug Bain |
source
presentation source |
16 |
| PHUSE EU |
2016 |
Clinical Data in Business Intelligence |
Mike Collinson |
source
presentation source |
7 |
| PHUSE EU |
2016 |
Does the Concept of a 'Sentient Enterprise' Apply to the Clinical Trial Execution Process? |
Peter Grolimund |
source
presentation source |
7 |
| PHUSE EU |
2016 |
End-to-end Data and Metadata: It's Not Only a Dream, It's a Reality |
Gerald Neveu |
source |
6 |
| PHUSE EU |
2016 |
What is high quality study metadata? |
Sergiy Sirichenko,
Max Kanevsky |
source
presentation source |
9 |
| PharmaSUG |
2016 |
What is high quality study metadata? |
Sergiy Sirichenko,
Max Kanevsky |
source |
9 |
| PHUSE EU |
2015 |
Managing Data Standards Libraries Compliance (to CDISC) |
Deborah Paletta |
source
presentation source |
7 |
| PharmaSUG CN |
2015 |
Automatic generating blankcrf.pdf for Rave Study |
Haiqiang Luo |
|
8 |
| PharmaSUG CN |
2015 |
SAS End-to-End solutions in Clinical Trial |
Emma Liu |
|
17 |
| PharmaSUG |
2015 |
Introducing a Similarity Statistic to Compare Data Libraries for Improving Program Efficiency for Similar Clinical Trials |
Taylor Markway,
Amanda Johnson |
source |
5 |
| PharmaSUG |
2015 |
Let SAS "Modify" Your Excel File |
Nelson Lee |
source |
5 |
| PharmaSUG |
2015 |
The Most Common Issues in Submission Data |
Sergiy Sirichenko,
Max Kanevsky |
source |
9 |
| PHUSE EU |
2014 |
Every Study is Special! - Governing Data Standards |
Chris Price,
Elizabeth Nicol |
source
presentation source |
12 |
| PHUSE EU |
2014 |
Leveraging R And Shiny for Point and Click ADaM Analysis [presentation] |
Ian Fleming |
source |
10 |
| 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 |
Clinical Data Dashboards for Centralized Monitoring Using SAS and Microsoft SharePoint |
Jagan Mohan Achi |
source |
9 |
| SGF |
2014 |
Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions Using SAS |
Karin LaPann,
Terek J. Peterson |
source |
19 |
| PHUSE EU |
2013 |
of 7 |
Jules Van der Zalm |
source
presentation source |
7 |
| 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 |
| PHUSE EU |
2012 |
Improving Data Management with Systems Integration and Next Generation Data Flow |
Richard Davies |
source
presentation source |
4 |
| PHUSE EU |
2012 |
New Era for Data Management - Redfine Collaboration |
Michaela Jahn |
source
presentation source |
6 |
| PHUSE EU |
2012 |
Optimizing Data Validation |
Andrew Newbigging |
source
presentation source |
10 |
| PharmaSUG |
2012 |
From InForm EDC Data to SAS Datasets using SAS Clinical Data Integration - Real Time |
Jitesh Nagaria |
source |
12 |
| PharmaSUG |
2012 |
Metadata: Some Fundamental Truths |
Frank C. DiIorio |
source |
10 |
| PHUSE EU |
2011 |
Queries management: Interfacing SAS with in-house EDC application |
Virginie Freytag,
Michel Toussaint |
source
poster source |
5 |
| PHUSE EU |
2011 |
Study Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata |
Philippe Verplancke |
source
presentation source |
5 |
| NESUG |
2011 |
Metadata: Some Fundamental Truths |
Frank C. DiIorio |
|
9 |
| WUSS |
2010 |
Normalized Editchecks Automated Tracking (N.E.A.T.) |
Frank Fan |
source |
11 |
| PHUSE EU |
2010 |
How to process data from clinical trails and their open label extensions |
Thomas Grupe,
Stephanie Bartsch |
source
presentation source |
5 |
| PHUSE EU |
2010 |
Using web service technologies for incremental, real-time transfers |
Andrew Newbigging |
source |
11 |
| PharmaSUG |
2010 |
Online Query Management System: An Innovative SAS/IntrNet Solution for Clinical Data Management |
Romain Miralles |
|
12 |
| PHUSE EU |
2009 |
From raw data to submission: A metadata-driven, repository-based process of data conversion to CDISC |
Dimitri Kutsenko |
source
presentation source |
7 |
| SGF |
2009 |
Backpacking Your Way through CDISC: A Budget-Minded Guide to Basic Concepts and Implementation |
Rachel Brown,
Jennifer K. Fulton |
source |
7 |
| PharmaSUG |
2008 |
SDTM, Plus or Minus |
Barry R. Cohen |
|
6 |
| SGF |
2008 |
The Evolution of SAS in Life Sciences Research and Development |
David Handelsman |
source |
10 |
| PharmaSUG |
2007 |
SDTM, Plus or Minus |
Barry R. Cohen |
|
6 |
| PHUSE EU |
2006 |
Interfering with Data Management by the Statistician |
Jim Groeneveld |
source |
6 |
| PharmaSUG |
2006 |
SAS Drug Development: Bringing Innovation to Life Sciences |
David Handelsman |
|
12 |
| PHUSE EU |
2005 |
An Introduction to CDISC - What is CDISC and Why Standards? |
Laurie Rose,
Becky Kush |
source |
41 |
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