Service Description

Quintiles was subcontracted for IRB submission and monitoring. They prepared the related documents. They sent CRA to hospital sites for monitoring visits.

What Went Well

They contacted IRB and got the approval for the study. They conducted well the monitoring visits in the hospitals. They were available and answered quicky to our questions.

What Could Be Improved

the CRA were not totally informed about the project. They should have received more training about the study and the drug.

Lessons Learned from the Experience

We learned that the size of the CRO is not always an advantage. They were able to act quicky and have a lot of resources. However they were not totally involved in our project. As a small company, this project was more important for us than for them.