PharmaSUG2025paper·US·Data Standards
Decoding Laboratory Toxicity Grading: Unlocking the Potential and Overcoming Challenges of CTCAE DS-123
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PharmaSUG2025paper·US·Data Standards
ADaM Fundamental Principles vs. Rules: Which to Follow, When, and Why? DS-126
PharmaSUG2025paper·US·Data Standards
A discussion of the new ADaM guidance (ADNCA and ADPPK) for pharmacokinetics. DS-169
PharmaSUG2025paper·US·Data Standards
What comes first, the chicken (ADSL) or the egg (ADNCA)? Modularize your covariate creation to support flexible analysis dataset implementation! DS-256
PharmaSUG2025paper·US·Data Standards
Cytokine Release Syndrome (CRS) – Data Collection, Clinical Database Integration and Analyses in a Dose Escalation Cell Therapy Trial DS-316
PharmaSUG2025paper·US·Data Standards
Creating JSON Transport Data for Regulatory Life Sciences DS-336
PharmaSUG2025paper·US·Data Standards
Efficient CDISC Controlled Terminology Mapping: An R-Based Automation Solution DS-338
PharmaSUG2025paper·US·Data Standards
Getting under the ‘umbrella’ of Specimen-based Findings Domains! DS-346
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Implementation of the Estimand Framework to Oncology Project with Time-to-Event Endpoints DS-107 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
From Statistical Programmer's Desk: Conquering FDA Inspections with Effective Quality Control Measures DS-122 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
ISI in Biopharmaceutical Development: Structure, Challenges, and Experience DS-129 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
From Data to Regulatory: Best Statistical Programming Practices for Population PK, Concentration-QTc and Exposure-Response Analyses DS-133 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Implementing CDISC SDTMIG v3.4: Practical Strategies and Lessons from Real-World Programming DS-134 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Leveraging the Company's Submission Library of Data Reviewer's Guides to Accelerate Data Validation with Pinnacle 21 DS-139 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Strategic Statistical Programming for ADR Table Generation in Regulatory Submissions and Corporate Applications DS-142 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Optimizing ISS Analysis for Multi-Indication Submissions DS-146 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Bridging the Gap: How to Prepare Analysis and Electronic Submission for Companion Diagnostics (CDx) Bridging Studies in China DS-163 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Streamlining Clinical Data Translation from Chinese to English: Ensuring Confidentiality and Efficiency in Pharmaceutical Partnerships DS-166 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Re-designing SDTM Automation: Maximizing CDASH Process Values and Understanding Code-Specs Relationship DS-167 Shanghai
PharmaSUG2025paper·China·Data Standards and Submission (DS)
Navigating Unit Standardization in Clinical Trials: Bridging FDA and SI Unit Requirements through LB and LC Domains DS-175 Shanghai