A global healthcare and technology company needed an expert review of medical imaging management in their pivotal oncology Phase 3 study. What Bracken found was serious: major errors and omissions requiring immediate correction, and an adjudication rate that was excessively high for the indication. The imaging program — a primary endpoint of the trial — was at risk.
The client made the decision to switch imaging CROs mid-study to preserve data integrity. Bracken was asked to step in, embed directly within the client's clinical team, and manage the transition — including the transfer of thousands of images and processes from one vendor to another, in a study enrolling over 700 participants, within a strict 3-month window.
What Made This So Difficult
Switching imaging CROs mid-pivotal-trial, with thousands of images in transfer and a 3-month deadline, while keeping enrollment running.
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
Embedded cross-functional management, parallel workstreams, and a rigorous reader selection and training program — all within 3 months.
Rapid Embed
Bracken immediately embedded within the client's clinical and operations team — becoming a cross-functional extension of their staff rather than an external consultant.
Vendor Transition Management
Took over full vendor management, working collaboratively with the new imaging CRO to define timelines, develop a new charter, and design a read process aligned with the protocol and regulatory requirements.
Parallel Workstreams
Triaged the multifunctional transition process into distinct parallel workstreams — compressing what would typically be a sequential process to meet the non-negotiable 3-month deadline.
Reader Selection & Training
Conducted a thorough review process to select new readers, followed by a 2-day in-person training program ensuring complete alignment before any reads began.
Performance Oversight
Implemented rigorous inter- and intra-reader variability monitoring throughout the process, ensuring readers were tracked carefully and consistently from kick-off through completion.
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.
