By eCliniqua Staff
October 1, 2012 | News Brief | WorldCare Clinical (WCC) has announced its new Endpoint Assessment Committee (EAC) services for blinded independent central review of clinical trial data. WCC’s EAC services include expert assessments by physicians drawn from multiple therapeutic areas for comprehensive efficacy and safety reviews.
“Increasingly an Endpoint Assessment Committee (EAC), which is an independent blinded assessment of clinical trial safety or efficacy data, is being requested by regulatory agencies in multiple therapeutic areas,” remarked Richard Walovitch, Ph.D., president of WorldCare Clinical. “Sponsors get the best shot at maximizing their chances of regulatory success and subsequently accelerating the drug development process when they work with a CRO that can offer a completely digital central review combined with access to experienced expert independent reviewers.
WCC’s unique 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
“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,” said Walovitch in a press release.
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.