WorldCare Clinical, LLC
(WCC), a 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.
For more information about WCC’s new service offering, visit:
http://www.wcclinical.com/our-expertise/#page-EAC-Services or call 1 (888) 816-4721.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.