Service Description

ICON was contracted to provide laboratory services and all clinical services for a global development program in MDD, specifically related to the conduct of one Phase 2 and two Phase 3 clinical trials. ICON was responsible for country and site selection, regulatory submissions, and all aspects of clinical conduct. Protocols were developed by the sponsor and executed by the CRO.

What Went Well

ICON provided strong regulatory knowledge of different country requirements required for start up and conduct of this global program. Approval for conduct of the trial was received in all but one proposed country. ICON executed the trial as outlined by the Sponsor. ICON did not provide scientific or operational suggestions into the conduct, even when given the opportunity to review documents such as the protocol.

What Could Be Improved

ICON did not challenge Sponsor assumptions on enrollment rates, despite their strong experience in the proposed regions and indication. The lack of input into initial plans and timelines created a need for a roll out of additional country participation and extension of timelines to meet enrollment goals. Initial input into the assumptions based on their experience would have eliminated the need for a near doubling of country participation. ICON, at times, was not receptive to Sponsor requirements or requests. At times, requests were challenged that were considered non-negotiable. Sponsor made the decision to utilize centralized ratings for this trial. ICON was not supportive of this decision.

Lessons Learned from the Experience

ICON did not share experiences where it would have been useful, yet challenged areas where the Sponsor had clear requirements. In working with ICON, it is important to have a strong understanding of needs, as there was limited collaboration on strategy. ICON would eventually contribute to delivery as requested, however this required strong conviction and leadership from the Sponsor.