Service Description

We asked Quintiles to provide the following services: with Protocol design, medical writing, country feasibility assessment, monitor, enrollment, data management and IVRS services through their joint venture company, Cenduit.

What Went Well

Quintiles had great experience in the therapeutic area and the indication. This helped with the protocol design and writing, in particular which scales to include and their impact on data/cost. Their global footprint allowed us to smoothly run this trial on various continents

What Could Be Improved

Given Quintiles experience running similar trials, we expected country selection/feasibility process to be a quick and smooth one, but it was a very drawn out process and with minimum input from Quintiles. Enrollment was expected to be slow given the crowded CNS space, but we also expected Q's experience to aid in the process and thought they would employ appropriate recruitment tactics. This didn't occur. Budgeting was off and we had to go back to management and ask for 30% more funding. Quintiles was off-budget and timeline.

Lessons Learned from the Experience

You typically expect a big CRO to have global footprint and good experience that'll have decreased their learning curve and increase efficiency on your study. However, this wasn't the case. Outside the box thinking occurred in some areas, i.e. medical writing, data management, but not in others, i.e. at Program director level. So this mostly depends on the folks you get assigned to your project, review their CV's carefully.