
Trial execution – start up – conduct – close out ; Covance did project mgmt, data mgmt, monitoring and stats/med. writing
Date: September 7, 2014
Service Description
2 pivitol studies to support product registration in several emerging markets.
What Went Well
They team from Covance were outstanding team players, transparent when issues were identified and partnered with study manager at Merck to come up with practical, compliant solutions. these were complex protocols in complex TAs. Although the trial got off on a slow start the team very capably completed the trials on time (actually ahead for HIV). Addressed head on challenges and got things done - Truly a collaborative team effort.
What Could Be Improved
There were multiple challenges during the start and conduct of the programs - database set up issues, site selection, central labs, contracts with sites but as I mentioned before the team worked very collaboratively, addressed the challenges, had honest discussions, although intense discussions sometimes, the teams were always respectful, were not afraid to challenge each other and ask hard questions and through team work got the programs completed with good quality.
Lessons Learned from the Experience
Good teams make all the difference - collaborative, flexibility, focus on getting things done, establishing credibility were all key to the success of these projects.