Central Reviews
Central Reviews
Our extensive team of board-certified, sub-specialty-trained radiologists have provided assessments on hundreds of clinical trials across therapeutic areas and MRMC reviews in all modalities.
Our company’s goal in any clinical trial we perform is to provide on-time data with maximum precision and accuracy. To help accomplish this goal, we rely on practicing, board-certified, sub-specialty-trained radiologists. The radiologists that perform on trials we manage are experts in the particular modality and indication to be assessed.
Our radiology review experience involves studies of all types and sizes. For example, we perform single-read studies involving one radiologist. We also perform complex, multi-year studies involving a double-read with adjudication among a geographically-dispersed team of 12 or more radiologists. We are also accustomed to performing eligibility and safety reads with rapid turnaround times across multiple modalities.
Our expert radiologists perform a blinded, Independent central review for clinical trials (BICR) of imaging data collected from sites in more than 70 countries that participate in clinical trials across all therapeutic areas. The radiologists use our customized platform and best-in-class analysis tools to perform their assessments of the imaging data.
A Well Designed and Conducted BICR Can Reduce Trial Costs
Simulation studies conducted in collaboration with Dr. Fenghai Duan, assistant professor with the Department of Biostatistics and Center for Statistical Science at Brown University, demonstrate that small changes in reader precision and accuracy can result in decreased trial sample size and ultimately trial costs. WCC believes that the results from its study can be applied to any BICR involving subjective clinical data. Our approach is the same for all BICRs – we leverage our relationship with Harvard and other leading teaching hospitals, allowing us to draw from the best subspecialty-trained, board-certified practicing physicians, who are then trained by WCC under a uniform system to maximize the precision and accuracy of data interpretation.BICR: The FDA Weighs In
The FDA’s 2011 Draft Guidance Standard for Clinical Trial Imaging Endpoints states that a blinded independent central review is often needed in situations where clinical site image interpretation is variable and results of image measurements are important for eligibility determination, safety and/or efficacy endpoints. “…the centralized process can better provide verifiable and uniform reader training as well as ongoing management of reader performance, ensuring that the process is accurate and that bias and variability are minimized…”
Independent Review Workflows
Whether your trial requires a single radiologist with a single modality, a double-blind read with adjudication and multiple modalities, or simply an image management platform, WorldPRO® can be configured to meet your specific needs. Complex workflows also support technical pre-measurement and EAC reviews, without requiring special hardware or in-depth training.To benefit from our expertise in blinded independent central reviews
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