
Set up and monitor large phase III trial
Date: June 24, 2014
Service Description
Icon was contracted to propose countries and sites, then implementing the trial through Ethics and all National authorizations + hospital contract process. Then Icon was in charge of all monitoring and data collection.
What Went Well
Icon provided a good site identification since only a few of the sites were non-active during the study. The monitoring was on track during the study.
What Could Be Improved
Patient recruitment could have been a domain with more focus for Icon for both the Project Manager and trial monitors.
Lessons Learned from the Experience
Icon was a good partner during the trial. Their management of study documents could have been improved, and in particular, for the TMF.