Maximizing Precision and Accuracy
WCC focuses on providing Blinded Independent Central Review (BICR) services in studies that often require sub-specialty endpoint assessments. To meet sponsor’s needs, WCC offers Cardiovascular Endpoint Committee (CEC) services to evaluate adverse events (AEs) using safety coding dictionaries including MedDRA. Leveraging our 20-year strategic relationship with Massachusetts General Hospital, WCC’s solution provides access to leading experts in cardiology and neurology to complete the safety reviews.
WCC designed its Cardiovascular Endpoint Committee solution in conjunction with sponsors to comply with the FDA and other regulatory agencies’ requirements for independent verification of safety events. This solution offers an adaptable service that resonates across multiple therapeutic areas.
- Maximizes precision and accuracy in your clinical trial.
- Uses comprehensive workflows that effectively identify and determine required Events of Interest (EoI).
- Provides a fully integrated digital portal application that captures/quantifies/consolidates virtually any type of clinical data that is easy-to-use and FDA 21 CFR Part11-compliant.
- Identifies Cardiovascular Endpoint Committees to meet the requirements of your protocol for the most accurate assessments.
- Cost-effectively collates/records MedDRA, or similar evaluations and is comprehensive and easy-to-use.
WorldPRO® : A Flexible Solution for BICR
WCC’s proprietary digital portal WorldPRO® provides Sponsors:
- With the ability to directly upload clinical/imaging data to WCC.
- An application that captures, quantifies and consolidates virtually any type of clinical data for interpretation by sub-specialty trained experts.
- System access to multiple clinical scientists at multiple locations to collate potential Eols for internal or external review.
- A smart work queue for automated adjudication workflow, enabling clinicians review data efficiently to further expedite the review process.
- A standardized scoring system to assess the degree of certainty of the Eol.
- With better ability to determine variance in AE coding between independent reviews, while maintaining training and testing programs that maximize the precision and accuracy of your trial.
- An organized easy-to-access format of final data to present to the FDA for audit.
Contact us today to find out more.