Phastar supported a sponsor in preparing an Integrated Summary of Safety (ISS) for an investigational product in facioscapulohumeral muscular dystrophy (FSHD), spanning 30 trials across Phase I–III and multiple indications.
Key Challenges:
- Legacy Data Standardization: 23 of 30 trials only had raw datasets, requiring extensive harmonization.
- Complex Data Conversion: Raw data mapped to SDTM using Phastar’s automation tool, adapted for multiple studies simultaneously.
- Regulatory Modifications: SAP changes impacted hundreds of outputs, requiring agile response.
- High Volume of Deliverables: 546 outputs across 7 integrated pools and 23 subpopulations.
- Aggressive Timelines: Dry Run 1 targeted within just 10 months.
Our Approach:
- Conducted a detailed gap analysis and developed a Study Data Standardization Plan.
- Customized automation tools for efficient SDTM and ADaM creation.
- Authored ISS SAP and TFL specifications, aligning with the sponsor’s cross-functional team.
- Provided clear communication for regulatory feedback and modifications.
- Applied dual programming to ensure highest-quality deliverables.
Outcome:
Phastar successfully delivered over 500 high-quality outputs within 10 months. The ISS was ready for regulatory submission, with a clear, standardized approach that strengthened collaboration across the sponsor’s team.
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