Interim analyses in Phase III trials are high-stakes and often come with evolving requirements and tight timelines. When frequent revisions and compressed schedules created additional challenges, Phastar partnered with the sponsor to deliver clarity, accuracy, and confidence.
Key challenges included:
- Late-stage requirement revisions
- Tight deadlines for comprehensive outputs
- Multiple dry runs with varying randomization schemes
- Aligning with sponsor statisticians who had differing priorities
Phastar’s tailored solutions:
- Developed the DMC charter and blinded/unblinded shells
- Produced outputs for five dry runs and the interim analysis meeting
- Established secure, compliant data transfer systems
- Conducted daily meetings with the sponsor for real-time alignment
- Advocated for inclusion of additional analyses requested by the DMC
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