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Medidata's Momentum

Founded in 1999, Medidata Solutions is at an interesting juncture. The company is old enough to be seasoned - and young enough to not have any antique products or services dangling around its neck like beads at Mardi Gras. Medidata recently opened an office in the UK. It's privately held and claims profitability. Medidata announced that its revenues for the first quarter of 2004 soared 230% compared to the same period last year.

Medidata has already completed almost 80 clinical trials using more than 3,000 investigator sites; one large trial has 500 sites. The New York City company has more than doubled in size, to 78 employees, in the past year.

At first, its main product, Rave, was a standalone application, a thin-client, Web-based technology to deliver electronic data capture (EDC) - except with the ability to handle dictionary coding, electronic signatures, even central lab and patient diary data. But now the software is bulking up, allowing the company to venture into the territory of larger companies providing site and data management and adverse-event tracking. Sites using the software can have PCs and Macs; Rave exports data into SAS, ASCII, and Oracle Clinical files.

While some vendors speak solemnly of "integration," Edward Ikeguchi rolls his eyes. He's a physician and Medidata's chief medical officer, one of two founders. "Integration means getting one data source to work well with another data source," he says drily. "Here, there is no integration. There is one product."

He's especially excited about Vision Developer. In a demo, the real-time, three-dimensional charting features of the Medidata application drill instantly, and impressively, into the itsy-bitsy details of which imaginary clinical sites are behind recruiting patients - and why. "As a reporting tool," he says, "this is unique in the EDC world. This could take away hours of collating paper or hours of customization by an EDC vendor."

In addition, Ikeguchi goes on to say, Medidata allows sponsors greater visibility of safety-related data, reporting when a drug may be causing anything from diarrhea to insomnia. There are a variety of techniques to collect adverse-events reports, but few vendors can present them directly from the EDC information, from one application. "We're not trying to carve out safety per se," he says. But it should be easier to query the data than it is with cumbersome integration projects that are often the norm today.

Some sponsors of clinical trials don't mind supporting multiple databases for a single trial. "It is remarkably expensive," Ikeguchi says. "It is remarkably redundant." And multiple databases create a slower path to analyze the data. Better, he says, to have all the facts in one place. "We're getting a product that combines the trial data and the metrics about the trial in one place."

"EDC is just as valuable in smaller studies," argues Ikeguchi. "You can not only clean that data but gather intelligence."

Medidata has a conciliatory attitude toward contract research organizations (CROs). Ikeguchi says some CROs may want to work with Medidata on behalf of sponsors using EDC. "We will work with them as resellers. That will be an initiative for us this year."

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