Case In Point
Flexible Clinical Operations for a Rare Disease Biotech
About Client
A small biotech company in the rare oncology space came to Everest for help with its Phase III study. The sponsor had a very small team and needed to rely heavily on a CRO partner to drive results.
Challenge
- The sponsor had previously worked with a large CRO and was very dissatisfied.
- Given these issues, the sponsor was cautious and needed a CRO that could offer stability, clear communication, and a solutions-driven mindset. They also required a partner who could integrate closely with their internal team and work creatively through unexpected hurdles.
Solution
- Scope of work included: clinical operations, regulatory submission support and ISS, TMF management, data management, biostatistics and statistical programming, and pharmacovigilance.
- Scouted more than 200 sites and onboarded more than 65.
- Developed standardized templates and communications to accelerate site start-up and enhance site engagement.
- Resolved complex lab kit assembly delays with creative workarounds to stay on schedule.
- Actively supported EDC vendor issues, including escalation and backfilling with Everest’s programming resources.
- Maintained persistence through staffing changes at sites to ensure all were activated on time.
Results
- FPI Achieved On Time: Despite staffing turnover and operational hurdles.
- Enrollment Completed Early: Thanks to strong site engagement and operational execution.
- Vendor Accountability: Everest maintained strong oversight and accountability over third-party vendors.
- Efficient Start-Up: Use of standardized templates and real-time tracking drove operational speed and clarity.
