Title : Functional service provider for biometrics

Client Situation

A young biotechnology company had outsourced its clinical trials, both study management and biometrics, to a full service CRO. The company was focused on the CNS (Central Nervous System) therapeutic area and the CRO had been chosen for its niche expertise in clinical study management for CNS trials and access to global sites. The CRO had the clinical database and staff for data management. But it had difficulty in recruiting and retaining experienced statistics and programming resources. This impacted the quality and timelines for the Biometrics deliverables, though subject recruitment and monitoring was on track. The CRF and database finalization was delayed and the decision criteria and stopping rules for the interim analysis were not finalized.