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Afferenz on EDC, Images, and Data Integration

By Mark D. Uehling

June 14, 2006 | There are people who think the outsourcing of IT to India will not affect the life sciences. Filling Bangalore office parks with engineers who can talk U.S. suburbanites through reinstalling Windows XP is one thing. Doing bench research on angiogenesis is another.

And then there are companies like Afferenz, which make us wonder if some U.S. concerns are lagging behind on laying the foundation for clinical trials. In some ways, Afferenz offers as many different technologies for clinical trials as the largest suppliers in the industry. Registrat, a Kentucky contract research organization (CRO) specializing in Phase IIIb and IV trials, is an enterprise customer.

Afferenz, for the record, is a clinical trial software division of MegaSoft Consulting. The Chennai-based Megasoft is publicly traded in India; its most recent filings suggest the company will have perhaps $22 million in revenues in 2006.

Afferenz reports that contract research organizations (CROs) are getting more interested in this technology, with some making enterprisewide decisions.

Company president Ven Thangaraj does not minimize the difficulty of integrating any two streams of clinical data but calmly sets out the case for the job being a bit easier in his shop. Afferenz, he reports, is competing on the ease with which clinical trials can be designed. “You build it once,” he says. “If the site wants to do EDC, perfect. If the site wants to do paper, fine.” With his trial design module, he says, there is no hand coding. No programming. “It’s drag and drop,” he says. “We don’t build trials any more. Our clients do.”

“We are the SAP of clinical trials,” says Thangaraj. “We have many modules. You choose what you want. You buy what you need. That concept has made SAP what it is. That concept works. But not in this industry. Yet.”

Electronic data capture (EDC) is becoming an accepted utility, he suggests. Many people supply it. It is useful, not controversial. “EDC is EDC, for a lot of practical purposes.” So he’s competing on price. “We can give them an unlimited license for a price that other ASP vendors might give for one or two trials.”

Afferenz has a holistic view of the various tools in the data management toolbox. “EDC can’t stand by itself,” Thangaraj says. “Clinical trial management can’t stand by itself. Personal digital assistants can’t stand by themselves. These all have to play together.”

Cardio Workout
Like Boston’s PHT, Afferenz is exploring tighter integration with medical devices: electrocardiograms (ECGs), for starters, but also instruments such as weight scales and glucose monitors. Thangaraj says that if the backend systems are built correctly, and the readouts from those instruments can be rendered in XML, it’s a relatively easy mapping exercise to get a glucose reading from patient number 1892 into a trial database. “We’re not redesigning the backend for that particular device,” says Thangaraj.

Of course, eResearch Technology of Philadelphia has long considered itself a leader in working with ECGs in clinical trials. But Thangaraj is not cowering. He says his company has also been working with lots of heart data and that it’s especially interesting from a data management perspective.

QT/QTc intervals are a tool to predict cardiac arrhythmias. But Thangaraj says the market for QT/QTc data from clinical trials is changing. “There is more push to automate that analysis,” he says, with sponsors interested in average QT times, elongated QT times, and other trends. “We can do the display, the capture,” he says of ECGs. “The automated analysis is what we are focusing on.”

He’s also continuing to push Afferenz’s ability to work with images. Moving 2-gigabyte files across a Web-browser interface is difficult; burning some of the data onto DVDs may be more sensible. The company’s familiarity with images has helped win business, Thangaraj reports, with 80 percent of potential customers asking about Afferenz’s image-handling abilities. He’s been waiting for that for years. “It’s attracting a lot more clients,” he says. “They have been asked by a regulatory authority to include images. It’s a good lead-in to say, ‘We can handle that and electronic case report forms as well.’ ”


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