Clinical Study Rescue / Transition

The Challenge: A client presents a challenging ongoing renal cancer vaccine study that is not meeting enrollment or site activation timelines. 

The Solution: Project Management immediately met with the client to assess what efforts have been exhausted and to also clarify exactly what was needed, which was more sites and patients in a short time period.  Many institutions were approached and either participating or previously declined.  MedSource Project Management (1) set up a relationship with a central Institutional Biosafety Ethics Committee (IBC), (2) solicited all community or comprehensive cancer center in the MedSource investigator database, (3) confirmed they were eligible to set up an IBC and assisted with this set up at each site, (4) verified available subject population and site qualification, and (5) initiated sites, all in less than 6 months.

The Result: All of the sites were activated in time to meet study enrollment timelines in early 2008 and these sites are now able to perform on vaccine or gene therapy studies when they were not previously set up to do so.