Case In Point
Rescuing Two Rare Hematologic Cancer Studies and Supporting an FDA Approval
About Client
Everest initially supported data management, biostatistics, and statistical programming services for a biotech company developing a treatment for rare hematologic cancers.
On the clinical side, challenges mounted with the incumbent global CRO, including significant delays, poor transparency, inaccurate reporting, and operational inefficiencies. So, the sponsor turned to Everest to assume full-service responsibility for two Phase III studies already in startup.
Challenge
Everest needed to quickly take control, clean up quality, address gaps, and make-up for lost time to complete the study on time.
Solution
- Executed a 1-month CRO transition with detailed planning and QA-supported documentation, assumed full control of all work streams.
- Efficiently took over site operations—identification, startup, initiations, monitoring, took over 3rd party vendors, activated new patient concierge services, transitioned drug depot operations.
- Delivered exceptional site engagement through experienced Clinical Operations Lead, CRAs, and Medical Monitor leadership.
- Enhanced service in drug safety, IRT, biometrics, pharmacovigilance, and depot management.
Results
- First SIV achieved 1-month post-transition.
- Completed enrollment on time for one study and ahead of schedule for the second study.
- High site engagement, leading to strong enrollment and data entry performance.
- Biometrics, pharmacovigilance, and depot management deemed top-tier.
- Topline in 6 days post DB-lock, CSR and data delivery for BLA submission to FDA.
- One of the rare hematologic cancer indications supported by these studies subsequently received FDA approval.
- During the regulatory review process, the FDA inspected Everest’s work and issued a No Action Indicated (NAI) classification with no findings.
