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

February 13, 2012

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

Boston, Mass., February 13, 2012 — WorldCare Clinical, LLC (WCC), a leading imaging CRO focused on maximizing the precision and accuracy of independent assessments in clinical trials, today 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;
  • Organization 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.

For more information about WCC’s new service offering, visit: http://wcclinical.com/what-we-do/special-services/cardiovascular-endpoint-committee-services.

About WorldCare Clinical

WorldCare Clinical (WCC) is a leading imaging CRO that employs imaging expertise, innovative technology and operational excellence to maximize the precision and accuracy of a blinded independent central review of clinical trial data. Originally founded in 1992 by the Massachusetts General Hospital (MGH) Department of Radiology, WCC has evolved as an independent company while maintaining a strategic relationship with MGH.  With a 20-year focus on imaging trials and their specific requirements, WCC provides sponsors with extensive medical, operational, and image management expertise in support of even the most complex study designs. For more information, visit wcclinical.com.

 

For more information, contact:

Bree Bolognese

SVM Public Relations

(760) 754-7025

bree.bolognese@svmpr.com