A global healthcare and technology company needed an expert review of how medical imaging in their pivotal Phase 3 oncology study was being managed by an imaging CRO. After Bracken's initial assessment, the team identified major errors and omissions — and an adjudication rate far above what the indication warranted.
What Made This Difficult
The client elected to switch imaging CROs mid-study to preserve data integrity — one of the most complex, high-stakes decisions in clinical trial management.
Transferring thousands of images and processes from one vendor to a new one under strict regulatory oversight
Rebuilding an entire read design and imaging charter aligned with both the protocol and FDA requirements
Selecting and training new readers — including a 2-day in-person training program — within a compressed timeline
Restoring fully operational imaging reads within 3 months for a study enrolling over 700 participants
How Bracken Solved It
Bracken embedded directly within the client's clinical and operations team — functioning as a cross-functional extension of their imaging leadership.
Vendor Transition Management
Bracken took over full management of the new imaging CRO from kick-off, collaborating to define timelines, develop a new read charter, and ensure complete alignment with the study protocol.
Parallel Workstream Triage
The team broke the transition into distinct parallel workstreams, enabling simultaneous progress across image transfer, reader selection, charter development, and regulatory alignment.
Reader Selection & Training
Bracken conducted a thorough reader review and delivered a 2-day in-person training program to ensure inter- and intra-reader consistency before reads commenced.
Measurable Outcomes
A successful imaging rescue study requires specialized expertise, compressed execution, and cross-functional leadership. Bracken's embedded model — operating across vendor management, regulatory strategy, and clinical operations simultaneously — is exactly what makes it possible.
Common Questions About This Topic
An imaging rescue study refers to an emergency intervention when an imaging CRO's performance threatens the integrity of a clinical trial. This typically involves switching vendors mid-study, transferring image data, and re-establishing reads — all while maintaining regulatory compliance and study timelines.
In Bracken's experience, a full imaging CRO transition — including image transfer, charter rebuild, reader selection, and training — can be accomplished in approximately 3 months when managed by an experienced embedded team with deep vendor oversight expertise.
Elevated adjudication rates are often caused by ambiguous read design, misaligned reader training, or lack of a rigorous imaging charter. Bracken addresses all three simultaneously through protocol-aligned charter development and structured reader training programs.
Sponsors should consider an imaging CRO transition when they identify systematic errors in image acquisition, analysis, or adjudication that cannot be corrected within the current vendor relationship — particularly when a pivotal study's data integrity is at risk.
