Navigating multi-therapeutic Phase III studies is complex. From strict blinding protocols to scheduling senior DMC members across multiple time zones, the challenges are significant. Phastar’s tailored approach ensures that every deliverable is managed efficiently, securely, and with the highest statistical rigor.
Key highlights from our case study:
- Full-Spectrum DMC Management: Over 45 blinded and unblinded outputs per meeting, including demographics, disposition, safety, and ad hoc efficacy analyses.
- Secure Data Handling: Transitioned from problematic shared folders to compliant sFTP systems, ensuring reliable and secure data sharing.
- Process Optimization: Streamlined workflows, facilitated smooth team handovers, and proactively resolved data quality issues.
- Stakeholder Integration: Seamlessly collaborated with sponsor and vendor teams, adding value without complexity.
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