
Monitoring, data managment, statistics, and medical writing
Date: June 24, 2014
Service Description
The CRO was in charge of the monitoring the data, the statistical analysis and the Clinical Study report.
What Went Well
The monitoring of this study was well done.
What Could Be Improved
The CRO was not flexible (for example, no possibility to change a table not described in the contract instead of another one). There was no real expertise in data managment (serious and severe are different thing).
Lessons Learned from the Experience
We feel this CRO is too big for us, too expensive and does not offer the flexibility we need.