There is a moment in almost every imaging-led clinical program when a sponsor realizes, too late, that the imaging CRO they selected cannot actually do what the trial demands of them. The reading center’s platform is not properly validated. The readers lack certification in the relevant indication. The imaging charter—the document that governs how every read will be conducted, adjudicated, and defended before a regulator—was never properly developed, let alone agreed with the Agency before data collection began. By that point, the choices are painful: continue and accept the regulatory risk, or stop, re-qualify a new vendor, and absorb the timeline and financial consequences.
This white paper is written for teams who want to mitigate risk and make that decision correctly the first time. It does not attempt to be comprehensive; it focuses on the considerations that most often separate a successful imaging CRO engagement from a troubled one, grounded in the FDA’s 2018 Clinical Trial Imaging Endpoint Process Standards, the new ICH E6(R3) requirements, and practical experience with how the industry operates.
The paper concludes by introducing the Imaging CRO Vendor Qualification Scorecard: a structured, evidence-based evaluation instrument that translates the principles discussed here into a cross-functional scoring tool suitable for regulatory filing.