WorldCare Clinical Expands Capabilities with Introduction of New Service Offering for Cardiovascular Endpoint Committees

Feb 14, 2012
By Applied Clinical Trials Editors

WorldCare Clinical, LLC (WCC)  introduced a new service offering that supports expert readers in a timely and transparent manner to complete cardiovascular endpoint committee reviews quickly and cost-effectively.

In response to FDA guidance and growing requests from other regulatory agencies that place new emphasis on assessing and minimizing cardiovascular risk, WCC has developed a comprehensive and easy-to-use solution for cost-effective, Blinded Independent Central Review (BICR) of adverse events (AEs) using the Medical Dictionary for Regulatory Activities (MedDRA) and other safety coding dictionaries. WCC’s new service offering builds upon the company’s extensive Endpoint Assessment Committee (EAC) services and employs its WorldPRO® image management platform to capture, quantify and consolidate virtually any type of clinical data for interpretation by sub-specialty trained experts.

"We’re excited to introduce the first of several new services we’ll be offering to sponsors in the coming months," said Richard Walovitch, PhD, president of WorldCare Clinical, LLC. "Through our long-standing strategic relationship with Massachusetts General Hospital (MGH), we’re able to deliver the most accurate assessments by providing access to leading clinical experts to meet each trial’s specific protocol requirements. This combined with our proprietary digital portal, WorldPRO, provides the ability to streamline the BICR process and highlights the flexibility of our capabilities."

WCC’s new service offering for cardiovascular endpoint committees consists of the following:

  • Upload of narratives and clinical data by sponsor/CRO via WorldPRO;

  • The ability for sites to upload imaging and other supportive information for review and analysis, if applicable;

  • Review of consolidated subject data by external MD to confirm need for assessment and complete QC;

  • Organiz ation of data into an easy-to-access format for FDA audit.

The WorldPRO system can be accessed by multiple clinical scientists at different locations to collate potential Events of Interest (EoIs) for internal or external review. Equipped with a smart work queue and automated adjudication workflow, WorldPRO allows clinicians to review data efficiently to further expedite the review process. Additionally, WCC has included a standardized scoring system to assess the degree of certainty of the EoI. This unique feature enables WCC to better determine variance in AE coding between independent reviews, while maintaining training and testing programs that maximize the precision and accuracy of a clinical trial.

 

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