Imaging for clinical trials is a hot area, and getting hotter. WorldCare Clinical is beefing up its image management system and tapping its access to top radiologists in the U.S. and less expensive locales.

The imaging-focused contract research organization (CRO) just hired industry veteran Richard Walovitch as its chief medical officer. Walovitch, who had been senior vice president of clinical research at Acusphere, has worked in the clinical and preclinical diagnostics field for more than two decades, and even helped draft the FDA's guidance on imaging in trials 15 years ago.

Before Acusphere, Walovitch was vice president of preclinical and clinical research at Epix Medical, and held various positions in the imaging agent group at DuPont Merck Pharmaceutical.

Critical Path

Now is the time to strike, says Walovitch. “It's becoming increasingly apparent that, based on Critical Path, the FDA is looking at medical imaging as a powerful tool to help in the development of pharmaceuticals,” he says, explaining that lately, many other divisions of FDA are making it easier to use medical imaging as an endpoint in a trial.

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WorldCare's Taranto

“Now you see the guidance for oncology referencing the imaging guidance. And last October, peripheral CNS had an advisory panel meeting, which is usually only for safety, and they were using imaging as markers for Alzheimer's disease. They said, 'We want to use imaging more aggressively.' We're trying to bring that imaging science to all our potential customers.”

Image Warehouse

At the same time that Walovitch is coming on board in the newly created role of CMO, WorldCare is beefing up WorldPro, its 18-month-old image-management system for trials. Early this month, the company launched a new component called Collect, Ready, Hold. It can store image acquisition protocols, identify and qualify sites, and standardize the image acquisition collection; perform administrative and technical quality control of the images submitted from study sites; and then archive the images in a database until a central review is required.

“It's our understanding that [competitors] may use multiple tools to do many of the same functions, but we are the only ones doing a single integration,” says Richard Taranto, WorldCare's president since 2005, formerly of Perceptive Informatics.

No Shipping

In the last 12 months, Taranto estimates that WorldPro, merely in its ability to receive images electronically, has helped clients save $465,000 in shopping costs. Money is also saved in time not spent finding data that have gone missing. To help avoid having to go back and do queries on data, the system checks it at the point of transmission to make sure it's in compliance. Once the data is in the system, it's available for viewing by all partners involved in managing it.

WorldPro also prompts coordinators to schedule follow-up visits with study subjects, and if they don't, the site itself is alerted. WorldPro contacts coordinators and other necessary parties outside itself, using email, texts, phone calls—whatever is necessary to drive coordinators and radiologists to the system for the next chore, says Taranto. Cost is per transaction.

Teleradiology Practice

Two years ago, the Cincinnati-based ProScan bought a majority stake (51 percent) in WorldCare. ProScan is one of the first companies to do teleradiology, using overseas radiologists to more cheaply read images for trials—and in ProScan's case, for clinical care. The majority of ProScan's radialogists are in the U.S., but some are in Iceland, Ukraine, Hong Kong and Israel. WorldCare clients were pleased.

"The high quality reads that we can offer through our strategic relationships become more cost-effective over the length of the trial, as the study requires less adjudication and the imaging data better correlate with efficacy endpoints," Taranto says.

Before ProScan, WorldCare considered itself a central imaging core lab. WorldCare was launched as a spin-off from the radiology department of Massachusetts General Hospital, which wanted to get involved in imaging for clinical trials, but didn't have the infrastructure, says Taranto. Originally named “Rstar,” it became WorldCare in 1995. Now the firm considers itself a CRO.

Walovitch says the connection with ProScan is promising. “We have a unique situation here,” he says. “We have ProScan radiologists who are doing the clinical day to day, and we have access to them for the routine stuff. We also have strong ties to Mass General when there are complicated protocols.”

Second AMC

The relationship with ProScan also gives WorldCare a connection to the University of Chicago Medical Center. WorldCare plus ProScan has 50 employees that work on trials (ProScan has additional employees that work on imaging in clinical care settings). Together, they do 20 to 25 trials per year, says Taranto.

Clients are a mix, from Fortune 500 companies to tiny biotechs with just one product moving through, says Taranto. Competitors, he adds, include RadPharma, Bio-Imaging Technologies, Perceptive Informatics and Icon Medical Imaging.

How's business? Excellent, despite the economic downturn. “Last year, there were lots of opportunities being put on hold as sponsors selected which product they were going to move forward with,” Taranto says. “This year is off to a great start as projects getting talked about last year are getting started.” And last year wasn't shabby either; Taranto says that in 2008 WorldCare grew 35 percent over 2007. This year, growth is expected to exceed that.

by Suz Redfearn

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