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Integrated Clinical Suite from India's MegaSoft

His technological vision included - back in 1999 - a recognition that XML and clinical standards were going to be important. "Version one was built around CDISC," Thangaraj says. "We said, 'It's going to happen.' We didn't know the timeline."

Before dirtying his hands with code, Thangaraj worked in imaging at Boston's Beth Israel Hospital, and his system has a component from that era of his life: the ability to integrate images from all the modern radiological modalities. In a demo, it was fascinating to see a case report form (CRF) come alive with a short neurological video documenting a patient's stroke. The software can export everything in a trial's clinical record - text, images, data - in one pass.

It was news to me, but many oncology trials are routinely using images. "A majority of oncology trials have an imaging component," says Thangaraj, explaining that different expert reviewers may be grading and sizing the patients' tumors over time. He notes some core labs do a nice business just combining the images with other patient data.

Thangaraj says he took pains, from the start, to protect the time of the database administrator (DBA). That meant allowing clinical managers to tweak their databases themselves. "We don't use programmers when we build trials," he says. "We've had no DBA required since version 1.1. You have to install Oracle. But once you've done that, it's hands off. A data manager can build a trial. Everything can be done in a point-and-click manner."

It's unusual to hear people readily explain what their products cannot do, but Thangaraj is as comfortable with that discussion as with discussing his product's strengths, such as easily taking diary data from handheld devices. His technology deploys quickly, starting a trial in a week or 10 days. The bottom line is that some customization is impossible. "If you wanted to show certain fields in certain pages based on answers in other pages, that's a feature we don't have right now," Thangaraj says.

Even so, there is too much functionality to describe here. Acceliant offers a CDM system. As for its CTM, which is a bit more stripped down, it cannot yet handle investigator payments. Other capabilities include project management, reports, messaging, and calendaring. The system can remind a site that a patient is due to come in. There are even advanced plans to use SMS to send patients reminders in countries where SMS usage is common.

Thangaraj is hoping to license his tools to contract research organizations, noting one large CRO is already a customer. "The CROs are losing money to the EDC vendors," he says. "They are having to share the money. Our clients get to keep all the revenue on a per-trial basis." Licensing the Acceliant application costs $8,000 - $12,000 per user.

Thangaraj's only liability may be his damned, cursed youth. He's in his mid-30s. "In our industry, you need gray hair," he says with a laugh. "People say, 'What is this kid doing here?' Maybe I will get some white hair."

One housekeeping note: MegaSoft is in the process of a name change to Afferenz, a transition that should be complete soon.

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