"Studies involving genetically engineered materials have the potential to bring incredible options to patients but involve greater complexity to operationalize. It’s imperative for sponsors, CROs, and vendor partners to work together in innovative ways to complete these trials in a timely fashion. This study was a high-profile trial for the sponsor and Parexel, requiring detailed preparation and critical path management. We worked diligently with our client success partners at Advarra to de-risk startup by pre-planning the site activation strategy, selecting sites from the Gene Therapy ReadyTM list, and pre-reviewing most of the IRB/ IBC site applications for potential issues early in the process. When it was time to review and activate sites, Advarra held 68 IBC meetings in one week to approve our first batch of sites. IRB review was right behind, with nearly all 145+ sites reviewed and approved within a couple of weeks. Advarra’s IBC services provided the full-service integration with the IRB we were seeking. We achieved the startup targets for sites utilizing the central IRB/IBC review service, the sponsor was delighted, and the research protocol was up and running in an impressive timeframe."