PHUSE2025Programming Languages
Standardised and Automated Template for Dose Escalation Decision-Making
Paper SM03
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Conference Papers
Find papers in official PHUSE, PharmaSUG, and WUSS proceedings. Search by title or paper number, then narrow the directory by conference, year, or category.
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PHUSE2025Programming Languages
Spot-It: A Shiny Application for Visual QC at Scale
Paper SM04
PHUSE2025Programming Languages
Write Concise ADaM Programs with If-less Programming Techniques
Paper SM05
PHUSE2025Programming Languages
An Intuitive Way to Derive the Last Known Alive Date in R
Paper SM06
PHUSE2025Programming Languages
Bridging the Gap: Creating and Debugging User-Defined R Functions from an SAS Programmer’s Perspective
Paper SM07
PHUSE2025Programming Languages
Accelerating PKPD Analysis with Automated DDI Variable Creation: An SAS-Based Approach
Paper SM08
PHUSE2025Programming Languages
Utility Macro for Ensuring Consistent Updates of CRF Data in SDTM
Paper SM09
PHUSE2025Programming Languages
Let’s Talk Future: Automated Solution for Standard-Compliant Data, Mock Shells and TFL Generation Using Open-Source Platforms with AI
Paper SM10
PHUSE2025Programming Languages
The R Test Kitchen: Cooking Up Quality in Clinical Analytics and Reporting
Paper SM11
PHUSE2025Programming Languages
Leveraging HASH Technologies for Enhanced Clinical Trial Programming Efficiency
Paper SM12
PHUSE2025Programming Languages
Let the Machine Do the Coding: A SAS-Based Framework for Automating TFL Generation with ARS Metadata
Paper SM13
PHUSE2025Programming Languages
Using Large Language Models for Consistency Checking of Tables, Listings and Graphs
Paper SM14
PHUSE2025Programming Languages
Kraken: A Shiny Application for Visualising SDTM Data in Early-Phase Clinical Trials
Paper SM15
PHUSE2025Programming Languages
Table Numbers Presentation Made Easy with Custom Functions
Paper SM16
PHUSE2025Regulatory Environment
Management of Regulatory Referenced Deliverables Workshop
Paper ODS
PHUSE2025Regulatory Environment
E2E R Submission from a Roche Oncology Study
Paper SA01
PHUSE2025Regulatory Environment
Management of Regulatory Submissions Using eCTD Sequences and Life Cycle Operators: Lessons from Real-Time Oncology Review (RTOR) and Regular Submissions
Paper SA03
PHUSE2025Regulatory Environment
Health Authority Interactions and Communication During the Submission Process
Paper SA04
PHUSE2025Regulatory Environment
From Application to Approval: Exploring the FDA’s Review Process
Paper SA05
PHUSE2025Regulatory Environment
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies
Paper SA06
PHUSE2025Regulatory Environment
Regulatory Challenges and Strategies for AI/ML-Enabled Medical Device (SaMD) Data Submission
Paper SA07
PHUSE2025Regulatory Environment
Double Trouble: Essential Insights from Successful Dual sBLA Submissions for a Drug-Device Combo
Paper SA09
PHUSE2025Regulatory Environment
Regulatory Submissions – Exciting, Challenging, or Both?
Paper SA10
PHUSE2025Regulatory Environment
Optimising Regulatory Submissions: The Role of eCTD, Real-World Evidence and AI
Paper SA11
PHUSE2025Regulatory Environment
Optimising the Development and Regulatory Submission of an eSUB Package for Exposure-Response and PK/PD Analysis
Paper SA12