Service Description

The CRO was contracted to provide Medical monitoring, site monitoring, project management, data management, vendor management and central lab services.

What Went Well

Overall the CRO barely met their responsibilities. Since there was dissatisfaction overall with the level of service and proactivity that were provided. The only truly positive aspect I can identify is that the Central Lab component went well, and the lab staff were responsive.

What Could Be Improved

The CRO was engaged to be a strategic partner. They were not. They acted exclusively as a tactical agent. Several directives were ignored and the quality of the Medical Monitoring was questionable. Vendor Management was completely non-existent and had to be taken over by the sponsor. Risk Management meetings were rarely held. In general this was a disappointing engagement

Lessons Learned from the Experience

This CRO required much more oversight than had been anticipated. They required more direct instruction than had been planned. They were not prepared to take specific direction form the steam and they did not understand what strategic engagement meant. Not only did they not think outside the box, they had little understanding of what the box was.