With its acquisition by Cincinnati-based ProScan Imaging in mid-2006, WorldCare Clinical (WCC) gained new radiological expertise in more than 20 subspecialty and “super subspecialty” areas that is available “on a moment’s notice” during clinical trials. The buyout also gave WCC the wherewithal to expand geographically beyond its headquarters near Massachusetts General Hospital (MGH) in Cambridge.

So says Stephen Pomeranz, M.D., WCC’s chief medical officer as well as ProScan’s founder, CEO, and medical director. “Along with an office in Cincinnati, we’re in the process of opening offices in Europe and Asia.” WCC established a strategic partnership with the University of Chicago in February, giving it further radiological expertise in basic research as well as oncology, neurology, and the neurovascular arena.

As an independent niche imaging contract research organization (CRO), WCC specializes in coordinating everything image-related within a clinical trial – including image acquisition protocol development, imaging site startup, independent central image-reading services, Web-based reporting, and quality control for regulatory compliance. Breadth of expertise is what separates WCC from the handful of other imaging CROs on the market, says CEO Rafael Mancera. It has experience in using every major imaging modality as well as access to more than 100 in-house general and high-level specialty radiologists at ProScan, MGH, and the University of Chicago.

WCC started in 1992 as part of the MGH Department of Radiology, with which it maintains a strategic relationship since it spun off as a separate company in 1995. From its inception, WCC is credited with processing more than one million images, enrolling over 35,000 patients, and serving more than 1,500 investigator sites in 47 countries.

ProScan, founded by Pomeranz in 1996, has grown into one of the largest and most respected teleradiology providers, imaging center operators, and advanced imaging and magnetic resonance imaging (MRI) educational centers in the United States. ProScan’s technologists and radiologists manage and read more than 1,000 advanced digital patient care cases per day on a global basis, says Pomeranz. At 50,000 to 100,000 slices per day, “we have as much, if not more, experience with teleradiology and the movement of digital medical images as anyone in the world.”

Patient-care images typically are transmitted to physician readers for interpretation via digital upload from imaging centers, using proprietary data-transfer technology, explains Mancera. The clinical trials business deploys similar technology in support of image transmission, where in addition to the studies, other pertinent information -- such as which trial arm the patient is in and whether the picture is a baseline or follow-up image -- is also sent on an attached image transfer form.

Sponsors have the final say-so regarding who reads trial-related images, says Pomeranz. Trials involving neurology, oncology, and musculoskeletal imaging hit the “sweet spot” of MGH and University of Chicago radiologists, while ProScan’s readers have unsurpassed experience with MRI, positron emission tomography scanning, and cardiac computed tomography scanning. Physicians are contracted on a case-by-case basis.

Besides reading images, WCC helps determine what will be measured and how images will be interpreted and presented to match FDA criteria, says Mancera. WCC also ensures that sites have the right equipment and technical know-how to acquire images as prescribed by the protocol – and leverages its expertise to maintain consistency of data and interpretation.

Some large trials require WCC to translate imaging site manuals into multiple languages. “If someone calls from Moscow with a question, we can do translation on the spot,” says Pomerenz. “At least 10 languages are spoken within ProScan headquarters alone. This in-house international flavor, added to our growing network of offices…help to make [WCC] a global player in the imaging CRO arena.”

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