PharmaSUG2023paper·US·Submission Standards
ADaM Datasets with Multiple Participations per Subject SS-146
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Conference Papers
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PharmaSUG2023paper·US·Submission Standards
Regulatory Data Submission and CDISC Compliance: Sponsor and Vendor Collaboration Best Practices SS-216
PharmaSUG2023paper·US·Submission Standards
BIMO Package: Challenges and Perspectives while keeping up with the upgrades in the BIMO Technical Conformance Guide and the BDRG Guidelines SS-217
PharmaSUG2023paper·US·Submission Standards
A case study of a successful RTOR submission and approval for Rylaze SS-223
PharmaSUG2023paper·US·Submission Standards
From FDA to PMDA submission: How to resolve CDISC non-compliance issues SS-224
PharmaSUG2023paper·US·Submission Standards
Recent updates in BIMO Technical conformance guidance and use case scenario SS-261
PharmaSUG2023paper·US·Submission Standards
Industry metrics for standards utilization and validation rules SS-266
PharmaSUG2023paper·US·Submission Standards
F2: FAIR and Filing – Assessing Data Fitness for FAIR and Filing SS-274
PharmaSUG2023paper·US·Submission Standards
Adopting the New Integrated Analysis Data Reviewer’s Guide (iADRG) SS-276
PharmaSUG2023paper·US·Submission Standards
Handling of Vaccine SDTM Data for FDA CBER/OVRR Submission Compliance SS-282
PharmaSUG2023paper·US·Submission Standards
As Simple as Falling Off a Log?: An Unusual Case Study of Mapping Data into the SDTM DA (Drug Accountability) Domain SS-304
PharmaSUG2023paper·US·e-Posters
Visualization for Success: Driving KPIs and Organizational Process Improvements via Portfolio-level Analytics PO-018
PharmaSUG2023paper·US·e-Posters
Creating a Centralized Controlled Terminology Mapping Repository PO-089
PharmaSUG2023paper·US·e-Posters
Programmer’s Perspective: Step into Awareness Regarding Clinical Trial Deliverables and Their Impact PO-119
PharmaSUG2023paper·US·e-Posters
A model for sponsors to support independent operation of IDMCs in clinical trials. PO-177
PharmaSUG2023paper·US·e-Posters
Data Doesn’t Lie – Real Time Monitoring and Projecting on Clinical Trial Enrollment Progression PO-294