Service Description

The CRO provided study management, site monitoring, and regulatory services. The CRO was conducted startup activities (ie CA/IRB/EC submissions, country/site feasibility), maintenance and close out (monitoring, issue resolution/CAPA).

What Went Well

The Regulatory submissions to CA/EC went well. CRO was able to provide expertise in informing us of what documents were required and timelines for approval. Also, CRO helped with addressing any questions received from CA/EC.

What Could Be Improved

The study manager did not drive the study. The sponsor had to remind and constantly follow up on times the PM should of had on their radar. Thus , a weak PM allowed other functions to slip (ie monitoring) which led to increase sponsor involvement on outsourced tasks and duplication of efforts.

Lessons Learned from the Experience

Lesson learned was to minimize CRO outsourcing and bring more functions in house to allow for more sponsor control. Outsourcing model will still be used (especially in countries like Japan) but it will be decreased. Excessive money was spent on outsourced tasks that were delivered below expectations.