Affirmations from Afferenz: EDC, Images, Integration


By eCliniqua Staff

May 8, 2006 | "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." 

Like Boston's PHT, Afferenz is exploring tighter integration with medical devices: electrocardiograms, for starters, but also instruments like 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 No. 1892 into a trial database. "We're not re-designing the backend for that particular device," says Thangaraj.  

Of course, eResearch Technology of Philadelphia has long considered itself a leader in working with electrocardiograms 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. As most readers know, QT/QTc intervals are a tool to predict cardiac arrhythmias. Nothing new there. 

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.' " 

Even back in India, he observes, there are signs of more ardent interest in EDC: "India is turning out to be a fertile market for us." He reports there are perhaps 80 CROs there, with both the world's largest names and one- and two-man operations vying for business. 

As with Western competitors, Thangaraj says, Indian CROs need to be able to look a sponsor in the eye and promise that EDC will be no big deal. "They are competing with CROs in the U.S. Companies in India have to say, "We can do EDC, too.' " 


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