PharmaSUG2019paper·US·Strategic Implementation, Business Administration, Support Resources
Dataset Specifications: Recipes for Efficiency and Quality SI-243
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PharmaSUG2019paper·US·Strategic Implementation, Business Administration, Support Resources
Using freelancers in the programming world – Challenges and opportunities SI-257
PharmaSUG2019paper·US·Strategic Implementation, Business Administration, Support Resources
Throw Away the Key: Blockchain-ed Healthcare Data SI-292
PharmaSUG2019paper·US·Strategic Implementation, Business Administration, Support Resources
Don’t Just Rely on Processes; Support Local Subject Matter Expertise SI-300
PharmaSUG2019paper·US·Strategic Implementation, Business Administration, Support Resources
Vendor’s Guide to Consistent, Reliable, and Timely CDISC Deliverables SI-320
PharmaSUG2019paper·US·Strategic Implementation, Business Administration, Support Resources
Begin with the End of Validation: Adapting QbD Approach in Statistical Programming to Achieve Quality and Compliance Excellence SI-327
PharmaSUG2019paper·US·Submission Standards
China NMPA (National Medical Products Administration) reform and new regulations/guidelines/requirements SS-014
PharmaSUG2019paper·US·Submission Standards
Progression-Free Survival (PFS) Analysis in Solid Tumor Clinical Studies SS-027
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