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Medidata Enters The Majors

By Mark D. Uehling

May 12, 2005 | Medidata Solutions, a New York City clinical technology vendor, has become the company to beat. It claims five enterprise-wide deals and that it has embarked on the largest trial ever to use electronic data capture (EDC), a global study involving 70,000 patients.

The biggest arrow in Medidata’s quiver? It has signed up a large new clinical technology customer. Bayer, the German chemical concern, selected Medidata to supplant its homegrown, laptop-based technology for gathering and managing clinical data.

“Bayer HealthCare views electronic clinical data management as an important component of our global focus on increasing clinical trial capacity while managing costs through standardizing on a common platform,” said Johann Proeve, head of data acquisition and data management. “A cross-functional team evaluated our alternatives, both internal and external, and concluded that Medidata’s Rave solution provided all markets with the most adaptable and extensive capabilities.”

The Bayer announcement could be a watershed for software vendors that support clinical trials. That’s because the Bayer decision indicates that Medidata’s technology passes muster with one of the largest companies in the world .

Bayer was one of the first companies to develop its own software for clinical trials. The architect of its EDC system, Sylva Collins, departed to do it again at Novartis with even more impressive results. The fact that Bayer’s system is apparently long in the tooth (or that Bayer seems to have felt Medidata was ready for prime time) will renew scrutiny of aging, pre-Internet applications  inside pharma.

Some sponsors of clinical trials, of course, maintain that vendors chronically overcharge and under-deliver. So it’s too early to announce the demise of proprietary clinical trial solutions: the pharmaceutical industry chooses technology partners with glacial speed and extreme caution.

But the Bayer decision will give new momentum to the vendor community at large and to Medidata in particular. The private company recently reported a 245 percent increase in sales for the first quarter of 2005 compared to the same period a year earlier. “We probably signed 25 or 30 percent of all the new EDC business in 2004,” says Tarek Sherif, Medidata’s CEO. “We just opened an office in Japan. We feel the momentum is going to continue.”

One especially bright spot: the contract research organizations (CROs), under both internal and customer pressure to be efficient. “There has been a sea change there,” says Sherif. “They’re changing their tune on EDC.” Medidata recently announced its first global CRO partnership with ICON Clinical, an Irish company.

Ten times bigger
Sherif does seem a bit more guarded than he has in the past, perhaps reflecting ten-fold growth in the company’s headcount since the end of 2002. With 190 employees and 46 completed trials, Medidata has captured market share from two leaders—Phase Forward and Oracle Clinical. Both of those companies are based in the Boston suburbs and have tried to pretend Medidata was not in their league. That will be harder now, especially with Medidata hiring a former Oracle executive, Keith Howells.

The most significant news at the company may be technological. Medidata is about to promote a little-publicized project with Janssen Pharmaceutica, a Johnson & Johnson company. After trying other EDC vendors with less satisfaction, Janssen has now happily used Medidata’s technology to go forward and backward at the same time.

Medidata has adapted its web-based platform to run on dedicated laptops (the aging approach at Bayer and Novartis). The twist is  the Medidata laptops are sufficiently secure that the approach has enabled the eradication of paper “source” documents in two trials at Janssen. Such e-source studies—and the avoidance of a paper quagmire—had been largely a theoretical proposition. But Janssen is comfortable with the security and regulatory issues surrounding the Medidata approach and plans to use e-source again.  l

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