Rethinking CRO Relationships
To avoid delays and cost overruns, one global biopharmaceutical company realized it had to do better when it came to CRO oversight.
Overview
The sponsor sought out a system that could provide real-time access to operational data in one place. The sponsor chose Operations Insights for CRO oversight and collaboration and Risk Based Monitoring for site performance.
Challenge
Poor data visibility, slow data reporting, and uncertainty about agreed-upon terms and quality plans were straining the sponsor’s relationship with its CROs. Information was siloed in nine different systems across three vendors and missed milestones regularly increased risk and added unnecessary costs.
Solution
Because the sponsor lacked the internal resources to create its own solution, executives looked at outside vendors for help. Saama was selected to integrate data into a common data model and use pre-built analytics to quickly identify issues.
Results
The new transparency enabled a more efficient use of resources and resulted in a more collaborative relationship between the sponsor and its CROs. Adverse events and protocol deviations are managed more quickly, performance has improved dramatically, and CRO change orders have markedly decreased.
