Were they dating? Engaged? It appears Wyeth and Medidata Solutions have been married for some time, at least from hints about “eleven months” of using electronic data capture in the news release that posted yesterday.

This week’s formal announcement is a seven-year, enterprise-wide uptake of Medidata’s EDC product by Wyeth. That big pharma has been one of the few to ponder the evolution of the EDC landscape deeply, and to have well-developed and publicly stated ideas on what the technology should be able to do for the industry as a whole. (Here’s a previous ClinPage story about a Wyeth presentation at the Clinical Trials Congress.)

Medidata’s co-founder, president and CEO Tarek Sherif checked in with ClinPage earlier this week. “It’s a big deal for Medidata,” says Sherif. “It’s also exciting industry-wide. Wyeth is very EDC-savvy. Wyeth is a great example of a company that is standardizing on EDC. They saw a company they wanted to partner with.”

Competitive Win

Medidata, for its part, vanquished its Boston-area rival, Phase Forward. On its call with Wall Street analysts this week, Phase Forward dismissed the Medidata-Wyeth announcement, contending it was something that had unfolded back in 2006. Medidata says the contract was signed recently.

But there’s no minimizing the significance of signing up a large, sophisticated customer that had used its own EDC technology. The number of large companies with home grown solutions is shrinking; Phase Forward and Medidata have also been able to pummel Oracle’s EDC product for the past several years.

Besides signing up 37 new customers in 2007, Medidata now claims seven enterprise customers, not all of which can be named. But Wyeth, Bayer, Astellas, Astra-Zeneca and three other unidentified firms are using it for the majority of their EDC studies. (Medidata also has nine contract research organization customers.)

Like every other supplier of EDC, Sherif says there is plenty of business to go around for all the companies in the space. But he believes a handful of top firms are getting a disproportionate share by their own sheer heft and name recognition. “There is a consolidation of market share that is happening,” he says. “The majority of business is accruing to the leaders in the space.”

Adaptive Angle

In the case of Wyeth, Sherif says the sponsor continued to check its customer references into this year. Sherif declined to speculate on why Wyeth chose Medidata, but acknowledged that the sponsor has more interest than most in ramping up adaptive designs. “We have been very involved in trying to lead the charge on the adaptive front, and [our EDC product] Rave is well suited to leading adaptive trials,” he says. “They are an organization that focuses on it.”

The deal is interesting in light of rumored customer restlessness at Medidata. Asked about service issues, Sherif said: “I wouldn’t characterize it as growing pains. We deal with very complicated technology and implementation thereof. If you’re winning in the marketplace, and we are winning in the marketplace, you have to be doing a lot of things right. We’ve learned a lot in the last couple of years. We’ve evolved and matured as an organization, both in terms of our service and our technology.”

Rumor Mill

As an example of a happy customer, Sherif cited Johnson & Johnson: “We are in a very good position there. Any comment to the contrary is disingenuous.”

Still, we may have heard a note of reserve or caution in his assessment of Medidata’s commanding position in the market. “EDC adoption is definitely ramping up. It’s an excellent market. We are right in there in terms of being one of the leaders in the space. That’s not to say you can’t have more than one.”

CDMS Transition?

The built-in functionality of some EDC systems, including that of Medidata, is supplanting the paper-management and data-cleaning capabilities of the behemoth clinical data management systems. Sherif says that legacy CDMS such as Clintrial (from Phase Forward) and Oracle Clinical will be retained at some companies and mothballed at others.

Says Sherif: “We are seeing a mixed view in the marketplace on that. I would not hold to the view that all sponsors are wed to their CDMS. A lot of the sponsors who we have relationships with are moving in the direction, longer term, of getting rid of their CDMS in favor of a unified platform like ours.”

Sherif says new places to store clean data will be attractive. Is that a clinical data repository? A warehouse? By whatever name, he says, the key is having one destination for the data. Says Sherif: “It becomes so compelling to put all of your data in a single place, report off it, maintain it for the time the FDA requires you to maintain it. As EDC becomes more of a mainstream technology, the focus will shift to things like repositories.”

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