Oncology Program Submission Readiness — SDTM/ADaM Standardization and Integrated
Analyses
Client background
A Bay Area–based sponsor developing oncology treatments for unmet needs. The company’s lead Phase II product candidates were being evaluated for their potential to provide improved survival rates for multiple indications.
Challenge
Deliver multiple, complex statistical analyses across several studies—producing Clinical Data Interchange Standards Consortium (CDISC)–compliant outputs and pooled datasets for New Drug Application (NDA) submission to FDA—with minimal sponsor oversight.
What we did
- Deployed a cross-functional team of 20 programmers and 4 statisticians to support pivotal Phase 2b and Phase 3 studies.
- Produced CDISC-compliant datasets for the pivotal studies.
- Conducted a CDISC gap assessment, reviewing Study Data Tabulation Model (SDTM) compliance for submission readiness.
- Converted legacy studies to SDTM where CDISC-compliant datasets were not available.
- Authored the Statistical Analysis Plan (SAP) for the Integrated Summary of Efficacy (ISE).
- Standardized across studies for the Integrated Summary of Safety (ISS) and executed pooling for ISS/ISE, mapping from study-level SDTM to Analysis Data Model (ADaM) datasets.
- Prepared reviewer guides for each submission component: Clinical SDTM Reviewer’s Guide (cSDRG) and ADaM Reviewer’s Guide (ADRG).
Why it worked
- Communication — Tight coordination within the project team and with the sponsor’s Lead Statistician ensured alignment and rapid decisions.
- Expertise — A CDISC subject-matter expert and senior biostatistician served as project leads, driving adherence to standards and effective cross-study harmonization.
- Flexibility — A global delivery model enabled around-the-clock progress and on-time milestones.
- Experience — Proactive engagement with the sponsor’s senior leadership supported a high-visibility, inspection-ready program.
- Efficiency — A streamlined, standardized approach across study-specific deliverables reduced rework and supported aggressive timelines.
