Service Description

CRO assessed sites with feasibility questionnaires. Responsible for IRB process. Investigator meetings. Site initiation and regular site monitoring. Sure contract payments. Close out of study.

What Went Well

Very good at identifying the IRB process at each site. Providing details of site progress and issues.

What Could Be Improved

Navigating through the study risks. It is one thing to identify issues but recommending and implementing them is another. Proactivity was not their strength. Also working to identify subjects with the site was too hands off. High turnover of staff not well managed, transitions should have been better.

Lessons Learned from the Experience

We learnt that we need to do more work than we planned. We also learnt that their turnover meant missed deadlines and suboptimal team cohesion. They were not driven to overcome obstacles.