PharmaSUG2023paper·US·Strategic Implementation & Innovation
Secret SAS – You Can Write eCTD Using ODS Word in SAS SI-235
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PharmaSUG2023paper·US·Strategic Implementation & Innovation
PHUSE Safety Analytics Working Group – Overview and Deliverables Update SI-277
PharmaSUG2023paper·US·Strategic Implementation & Innovation
Auto-validation of SAS Macros through Regression Testing SI-302
PharmaSUG2023paper·US·Submission Standards
Handling CRS/NT Data in CAR-T Studies and Submission SS-003
PharmaSUG2023paper·US·Submission Standards
Optimizing Efficiency and Improving Data Quality through Meaningful Custom Fix Tips and Explanations SS-045
PharmaSUG2023paper·US·Submission Standards
CDISC Conformance and Compliance: So Many Resources, So Little Time! SS-059
PharmaSUG2023paper·US·Submission Standards
Study Data Technical Rejection Criteria (TRC) Considerations for Multiple Data Packages in a Single Submission SS-097
PharmaSUG2023paper·US·Submission Standards
Standardization of Reactogenicity Data into Findings SS-112
PharmaSUG2023paper·US·Submission Standards
Consistency Checks Automation across Regulatory Submission Documents in the eCTD M5 folder SS-117
PharmaSUG2023paper·US·Submission Standards
How Can I Put This? – Using a pre-defined spreadsheet to explain your Pinnacle 21 Enterprise Issues SS-124
PharmaSUG2023paper·US·Submission Standards
Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE SS-127
PharmaSUG2023paper·US·Submission Standards
Working with Biomedical Concepts and SDTM Dataset Specializations for Define-XML using SAS© Open CST SS-140
PharmaSUG2023paper·US·Submission Standards
ADaM Datasets with Multiple Participations per Subject SS-146
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