Endpoint Assessment Committee Services Bring Precision and Accuracy to Blinded Independent Central Review
Boston, MA, October 1, 2012 — WorldCare Clinical, LLC (WCC), a leading CRO focused on maximizing the precision and accuracy of independent assessments in clinical trials, today announced its new Endpoint Assessment Committee (EAC) services for blinded independent central review (BICR) of clinical trial data. WCC’s EAC services include expert assessments by physicians drawn from multiple therapeutic areas for comprehensive efficacy and safety reviews.
The unique depth and breadth of WCC’s strategic relationship with Massachusetts General Hospital (MGH) allows it to pull world-class, subspecialty-trained physicians from across departments for reads. From radiology and dermatology to oncology, cardiology and neurology, WCC provides blinded independent assessments by subspecialty-trained, board-certified experts, who are trained by WCC under a uniform system to maximize the precision and accuracy of data interpretation.
“WorldCare Clinical is excited to unveil our Endpoint Assessment Committee offering to pharmaceutical and biotechnology companies conducting trials that depend on subjective endpoint assessments,” said Richard Walovitch, Ph.D., president of WorldCare Clinical. “Our long-standing, cross-department relationship with MGH allows us to draw from the best independent readers. Across multiple therapeutic areas, the FDA is increasingly requiring EAC review of critical data for registration trials. We believe our EAC offering will enable sponsors to maximize their chances of regulatory success, by providing a more accurate and less variable interpretation of critical trial data.”
WCC’s WorldPRO data management platform captures and consolidates all data, including images, pathology slides, pictures of skin lesions, patient feedback, and more, and organizes data for a digital central review and streamlined submission to the FDA. This unique solution facilitates fast turnaround time for reviews and presents data uniformly to multi-discipline reviewers to enable the first-ever completely digital central assessment of subjective endpoints for maximum regulatory impact. For both trials that include an imaging component and those that do not, WCC can execute a BICR of any type of clinical data.
To support the release of its new EAC service offering, WCC has released a white paper titled, “A ‘Second Opinion’ for Subjective Endpoints: The Case for an Endpoint Assessment Committee.” To download a copy, visit worldcareclinical.com/about-us/eac-white-paper/. For more information on WCC’s EAC services, visit:
worldcareclinical.com/our-expertise/#page-EAC-Services or call 1 (888) 816-4721.
About WorldCare Clinical
WorldCare Clinical (WCC) is a leading imaging CRO that employs imaging expertise, innovative technology and operational excellence to maximize the precision and accuracy of a blinded independent central review of clinical trial data. Originally founded in 1992 by the Massachusetts General Hospital (MGH) Department of Radiology, WCC has evolved as an independent company while maintaining a strategic relationship with MGH. With a 20-year focus on imaging trials and their specific requirements, WCC provides sponsors with extensive medical, operational, and image management expertise in support of even the most complex study designs. For more information, visit worldcareclinical.com.
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