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WorldCare Clinical launches clinical trials review service at request of FDA

By Natalie Morrison , 02-Oct-2012
Last updated the 02-Oct-2012 at 12:46 GMT

Endpoint Assessment Committee (EAC) will perform blind assessments of a range of endpoints to speed FDA approval
Endpoint Assessment Committee (EAC) will perform blind assessments of a range of endpoints to speed FDA approval

WorldCare Clinical has launched a blinded independent safety and efficacy review service to speed FDA approval of clinical trial data.

The service is carried out by the new Endpoint Assessment Committee (EAC) made up of physicians from a range of therapy specialties including radiology and dermatology to oncology, cardiology and neurology.

The imaging CRO (contract research organisation) says the move will help pharma and biotech firms struggling in a time of greater regulatory pressure by providing a “less variable interpretation” of clinical trial data.

President of WorldCare Clinical Richard Walovitch also told Outsourcing-Pharma.com there has been a higher demand for the service from the US Food and Drug Administration (FDA), which is “increasingly requiring EAC review of critical data for registration trials.”

Walovitch said: “WCC is offering this service in response to requests from regulatory agencies to sponsors to include blinded independent central review of subjective data to minimize variability and maximize data integrity.”

The platform

The team will use WorldCare’s WorldPRO data management platform, which captures and consolidates all data including images, pathology slides, pictures of skin lesions and patient feedback.

“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,” the company said in a statement.

Despite WorldCare’s speciality, the system will support “any type of clinical data,” including trials that do not contain an imaging component.

Of the type of client the firm is targeting, Walovitch was quite coy saying only: “This service is applicable to pharmaceutical and biotechnology companies with clinical trials in multiple therapeutic areas.”

He did say however that the service is one “many sponsors will require and is not limited to smaller start-ups.”

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