Case In Point
Successful Rescue of Two Full-Service Oncology Studies
About Client
Everest initially supported data management, biostatistics and statistical programming services for an oncology biotech.
On the clinical side, the biotech grew frustrated by significant delays, inaccurate reporting, poor transparency, and inefficiencies from their larger global CRO. The company ultimately turned to Everest to take over the two Phase III ongoing studies that were already in start-up.
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.
- Recent FDA inspection of Everest indicated no findings with a No Actions Indicated (NAI) recommendation.
- Everest and the sponsor are awaiting FDA approval.
