Phastar supported a sponsor in preparing an Integrated Summary of Safety (ISS) for an investigational drug in sickle cell disease, pooling data from three studies: two Phase 3 randomized trials (single- and multiple-dose) and one open-label extension.
Key Challenges:
- Inconsistent ADaM Structures: Critical domains (ADSL, ADLB, ADAE, ADVS) required reconciliation.
- Varying Safety Set Definitions: Differences across studies complicated treatment and baseline flag creation.
- Complex Derived Variables: ADAE derivations demanded strict adherence to coding standards.
- Compliance Calculation Discrepancies: Divergent approaches had to be standardized.
- MedDRA Up-Versioning: Two up-versioning steps were required for consistent adverse event coding.
Our Approach:
- Standardized ADaM structures across all studies.
- Implemented flexible flagging logic to accommodate differing safety sets.
- Designed robust logic for complex ADAE derivations, ensuring consistent adverse event capture.
- Aligned compliance calculations with a body weight–adjusted formula.
- Managed MedDRA up-versioning to maintain data integrity.
- Maintained strong client engagement with weekly operational meetings to ensure rapid issue resolution and alignment.
Complete the form to read the full case study
