The use of imaging endpoints in clinical trials has increased steadily over the last 30 years. When an imaging core lab (ICL) — sometimes called an imaging CRO — is involved, biopharma sponsors find themselves heavily dependent on an entity whose operations they may know little about. That knowledge gap creates real risk: inadequate oversight of ICLs can lead to data quality failures, protocol misalignment, and costly delays.
Bracken's imaging experts serve as the knowledgeable intermediary between sponsors and their ICLs — providing the expertise that sponsors typically don't have in-house, and speaking the language that ICLs respect.
The Knowledge Gap That Creates Risk
Sponsors lack imaging expertise. ICLs lack biopharma context. Without an expert bridge, that gap becomes a liability.
Typical sponsor teams are not expert in imaging — creating significant dependency on ICLs they may not be equipped to oversee
ICL teams are not typically expert in biopharmaceutical development — communication gaps lead to misalignment
Inadequate ICL oversight can produce data quality failures, protocol deviations, and regulatory risk
Problems often surface late — at interim analysis or beyond — when course-correction is most costly
Sponsors have no structured way to objectively evaluate ICL recommendations and procedures
How Bracken Bridges Sponsors and ICLs
Bracken acts as an embedded imaging expert and objective intermediary — bridging sponsor and ICL to protect data quality, ensure protocol alignment, and resolve problems at their root.
ICL Assessment
Objectively evaluated ICL recommendations, procedures, and proposed approaches — identifying where the ICL's preferred system did not align with the sponsor's endpoints and needs
Communication Bridge
Served as the expert intermediary between sponsor and ICL — enabling effective communication and collaborative problem-solving where knowledge gaps had previously caused misalignment
Charter & Read Design
Provided critical guidance on imaging charter development, number of readers, reader training approach, and read design considerations to ensure full protocol alignment
Protocol Optimization
Supported protocol development from the earliest stages — optimizing imaging endpoints, imaging guidance documents, and charter design to minimize downstream risk
Embedded Expert Support
Provided clients with the benefits of an in-house imaging expert — without the need to hire permanent staff — enabling results to be available on time for NDA submission
Measurable Outcomes
If you're using imaging endpoints in your trial, the question isn't whether you need imaging expertise — it's whether you have it. Bracken's embedded model gives sponsors an expert ally at the table, the ability to objectively evaluate ICL performance, and the guidance needed to protect data integrity from protocol development through NDA submission.
Common Questions About Imaging Endpoints and ICL Management in Clinical Trials
An imaging core lab (ICL) and an imaging CRO (Contract Research Organization) are often used interchangeably, though ICL more specifically refers to the centralized facility responsible for receiving, processing, and analyzing imaging data from clinical trial sites. ICLs provide independent, blinded image assessment — which is critical for regulatory credibility — while also managing the operational and technical infrastructure of imaging in multi-site trials.
Common imaging endpoints include tumor response assessment by RECIST criteria in oncology, bone density and body composition by DXA in musculoskeletal and metabolic studies, brain volume and lesion quantification by MRI in neurology, and cardiac function measurement by echocardiography or MRI in cardiovascular trials. The choice of imaging endpoint depends on the indication, regulatory precedent, and the specific biological changes the trial is designed to detect.
Sponsors should evaluate ICLs on their therapeutic area experience, reader qualifications and training processes, technical infrastructure, quality management systems, and regulatory track record. Bracken recommends engaging imaging experts early in the process — before an ICL is selected — to objectively evaluate proposals, ensure the ICL's preferred approach aligns with the protocol, and negotiate charter terms that protect the sponsor's interests.
The earlier the better. Bracken can add the most value during protocol development — optimizing imaging endpoints, designing the imaging charter, and specifying ICL requirements before the RFP process begins. However, Bracken also provides critical value mid-study: identifying performance issues, correcting communication breakdowns between sponsor and ICL, and implementing course corrections before they affect data integrity.
