The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
|Articles|September 20, 2011
WorldCare Clinical's WorldPRO Suite Evolves to Support Complex Endpoint Assessment Committee Reviews
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WorldCare Clinical
announced a major release of its WorldPRO image management platform, a comprehensive system that collects, integrates and presents data to multiple reviewers in a regulatory compliant, efficient and effective manner. With the new version of WorldPRO, multiple clinicians can now access and evaluate data in preparation of an endpoint assessment committee review.
"We’re seeing an increase in the use of EACs, particularly in oncology trials, partially in response to regulatory agencies looking for an integrated assessment of patient outcomes," said Richard Walovitch, PhD, president of WorldCare Clinical, LLC. "The enhancements we’ve made to our WorldPRO platform ensures that sponsors can benefit from a holistic assessment of disease. Leveraging our relationship with Massachusetts General Hospital, we are able to provide oncology, pathology, dermatology, and oncology reviews by clinicians who apply practices used in patient care to the clinical trial setting."
By providing fully automated functionality for imaging data management, cli nical data management, image analysis, project management, and full trial transparency in a 21 CRF-compliant solution, the WorldPRO platform streamlines and improves the blinded independent central review (BICR) process by ensuring sponsors have complete control over trial data every step of the way.
The latest version includes updated features designed to further enhance the flexibility and configurability of WorldPRO to accommodate complex workflows, integrating the review of radiology, pathology, photography, and clinical data. This integration enables a more efficient review, reducing study timelines and improving data accuracy. In addition to delivering significant operational efficiencies to sponsors, WorldPRO provides complete transparency throughout the course of a trial by enabling sponsors to confirm that all data has been properly obtained and received from investigators before final blinded assessment, and minimizes unnecessary re-reads that can negatively impact chances for FDA approval. WCC’s fully digital process removes bias in data handling, and an efficient data management system streamlines all data capture and transmission to optimize workflow and ensure total control throughout.
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