PharmaSUG2019paper·US·Submission Standards
Progression-Free Survival (PFS) Analysis in Solid Tumor Clinical Studies SS-027
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PharmaSUG2019paper·US·Submission Standards
Clinical Development Standards for FDA Bioresearch Monitoring (BIMO) Submissions SS-030
PharmaSUG2019paper·US·Submission Standards
Practical Guidance for ADaM Dataset Specifications and Define.xml SS-056
PharmaSUG2019paper·US·Submission Standards
Enforcing Standards in an Organization: A Practical 6 Step-Approach SS-068
PharmaSUG2019paper·US·Submission Standards
A Practical Guide to the Issues Summary in the Data Conformance Summary of Reviewer’s Guides SS-092
PharmaSUG2019paper·US·Submission Standards
An Automated, Metadata Approach to Electronic Dataset Submissions SS-120
PharmaSUG2019paper·US·Submission Standards
Considerations in Effectively Generating PK Analysis Input Datasets SS-126
PharmaSUG2019paper·US·Submission Standards
Next Innovation in Pharma – CDISC data and Machine Learning SS-134
PharmaSUG2019paper·US·Submission Standards
Multiple Studies BIMO Submission Package – A Programmer’s Perspective SS-162
PharmaSUG2019paper·US·Submission Standards
Pharmacokinetic Parameters for Sparse and Intensive Sampling – Nonclinical and Clinical Studies SS-172
PharmaSUG2019paper·US·Submission Standards
Process optimization for efficient and smooth e-data submissions to both FDA and PMDA SS-217
PharmaSUG2019paper·US·Submission Standards
Sponsor Considerations for Building a Reviewer’s Guide to Facilitate BIMO (Bioresearch Monitoring) Review SS-240
PharmaSUG2019paper·US·Submission Standards
The Need for Therapeutic Area User Guide Implementation SS-273
PharmaSUG2019paper·US·Submission Standards
Making Lab Toxicity Tables Less Toxic on Your Brain SS-306
PharmaSUG2019paper·US·Submission Standards
Expediting Drug Approval: Real Time Oncology Review Pilot Program SS-309