PharmaSUG2024Strategic Implementation & Innovation
The Role of the Blinded Programmer in Preparation of Data Monitoring Committee Packages (for Clinical Trials)
Paper SI-185
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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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PharmaSUG2024Strategic Implementation & Innovation
Automating the annotation of TLF mocks Using Generative AI
Paper SI-189
PharmaSUG2024Strategic Implementation & Innovation
Navigating Success: Exploring AI-Assisted Approaches in Predicting and Evaluating Outcome of Clinical Trials and Submissions
Paper SI-190
PharmaSUG2024Strategic Implementation & Innovation
Quality Assurance within Statistical Programming: A Systemic Way to Improve Quality Control
Paper SI-230
PharmaSUG2024Strategic Implementation & Innovation
Validating R for Pharma – Streamlining the Validation of Open-Source R Packages within Highly Regulated Pharmaceutical Work
Paper SI-269
PharmaSUG2024Strategic Implementation & Innovation
PHUSE Safety Analytics Working Group – Overview and Deliverables Update
Paper SI-291
PharmaSUG2024Strategic Implementation & Innovation
A Change is Gonna Come: Maintaining Company Culture, Managing Time Zones, and Integrating Teams after a Global Acquisition
Paper SI-319
PharmaSUG2024Strategic Implementation & Innovation
aCRF Copilot: Pioneering AI/ML Assisted CRF Annotation for Enhanced Clinical Data Management Efficiency
Paper SI-346
PharmaSUG2024Strategic Implementation & Innovation
SASBuddy: Enhancing SAS Programming with Large Language Model Integration
Paper SI-362
PharmaSUG2024Strategic Implementation & Innovation
Facilitating Seamless SAS-to-R Transition in Clinical Data Analysis: A Finetuned LLM Approach
Paper SI-391
PharmaSUG2024Strategic Implementation & Innovation
Agile Sponsor Oversight of Statistical Programming Activities
Paper SI-408
PharmaSUG2024Strategic Implementation & Innovation
One size does not fit all: The need and art of customizing SCE and MDR for end users
Paper SI-446
PharmaSUG2024Strategic Implementation & Innovation
Embracing Diversity in Statistical Computing Environments: A Multi-Language Approach
Paper SI-452
PharmaSUG2024Submission Standards
BIMO Brilliance: Your Path to Compliance Resilience
Paper SS-132
PharmaSUG2024Submission Standards
Cultivating Success with Non-standard Investigator-sponsored Trial Data for FDA Submissions
Paper SS-133
PharmaSUG2024Submission Standards
Study Start Date – Let’s Get it Right!
Paper SS-137
PharmaSUG2024Submission Standards
Is a Participation-Level ADaM Dataset a Solution for Submitting Integration Data to FDA?
Paper SS-213
PharmaSUG2024Submission Standards
Creating Adverse Event Tables using R and SASSY System
Paper SS-263
PharmaSUG2024Submission Standards
Combine PDFs in Submission-ready Format Quick and Easy
Paper SS-290
PharmaSUG2024Submission Standards
Leveraging SAS and Adobe Plug-in for CRF Bookmark Generation (Rave studies)
Paper SS-306
PharmaSUG2024Submission Standards
How to generate a submission ready ADaM for complex data
Paper SS-311
PharmaSUG2024Submission Standards
Lead-in and extension trials, how we documented datapoint traceability
Paper SS-333
PharmaSUG2024Submission Standards
Piloting into the Future: Publicly available R-based Submissions to the FDA
Paper SS-344
PharmaSUG2024Submission Standards
A Programmer’s Insight into an Alternative to TQT Study Data Submission
Paper SS-363
PharmaSUG2024Submission Standards
Design Considerations for ADaM Protocol Deviations Dataset in Vaccine Studies
Paper SS-368