ICON Review: Site Feasibility, Startup, Site Management and Regulatory/Ethics Submission

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South County Business Park
Leopardstown, Dublin 18
+353 (1) 291 2000

Site Feasibility, Startup, Site Management and Regulatory/Ethics Submission

Overall: 2 stars

Date: June 24, 2014

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Service Description

The CRO was contracted to provide country and site level feasibility, site startup, regulatory / ethics submission, site management (site monitoring) services including project oversight and management for a Phase II AML oncology trial. The CRO was seleted after a competitive bidding process. No specialized services outside the regular scope of a full service CRO were included.

What Went Well

The CRO met our expectations in terms of working collaboratively to execute the vendor agreement prior to study start, assembling the CRO study team, attending kick-off and planning meetings and setting up study plans and timelines. The team trainings occurred on schedule and the study started as planned. The CRAs provided initially appeard to meet sponsor requirements.

What Could Be Improved

Initially all started off well, but in the first quarter of the study, deliverables for site initiation and enrollment began to signifigantly fall behind. Additional resources were added and it got caught up, but once patients began to be enrolled then Source Document Verification (SDV) and query resolution signifcantly fell behind. Despite frequent meetings on the subject and extra measures put in place it was continually a problem for the life fo the study. Looking back a lessons learned, the lead CRA managment should have identifed the under performing CRAs sooner and taken proactive measures to ensure that the CRO delivered on the milestones rather then continually promising to catch up be not delivering.

Lessons Learned from the Experience

We learned that a CRO may not always provide the best personnel for a team if there are other competing priorities. Also it is key to ensure a high level of oversight from the beginnng of a trial and that bringing in independent rescue CRAs is sometimes necessary if CRO cannot provide level of expertise or competence needed. We learned that the CRO was likely to promise to deliver without having a viable plan to do so.