Safety reporting tool leads Medidata to strong 2009

Trial-design, site-contracting, and safety-reporting tools are behind the 33 percent growth that solutions provider Medidata realized in 2009. President Glen de Vries says in an interview that product cross-selling and the fourth-quarter debut of the Rave Safety Gateway are major drivers.

Cross-sell efforts based on the company's Rave platform boosted sales of Medidata Designer, a protocol authoring tool. Four customers began piloting the system in the fourth quarter. Existing customers are also adding Rave Grants Manager software for site contract negotiations; two Rave customers began pilots in Q4.

De Vries says customers are asking how many separate trial-function systems Rave can replace. "That's evidence to us that the industry is changing."

The company launched the Rave Safety Gateway extension in December, aimed at simplifying safety event reporting. It allows a sponsor's legacy safety reporting systems to use data already collected and cleaned in Rave, streamlining the process of preparing data for submission. "Safety Gateway came from the fact that customers are looking for efficiency in the safety hand-off--in the reconciliation of trial and safety data." says de Vries.

Heightened FDA interest in safety, as witnessed by the regulator's increasing requirement for risk evaluation and mitigation strategies, is driving demand for safety tools. "REMS requirements are similar to what's been happening in Japan for years," he says. "We've been doing post-market studies there that are just like REMS studies. Sponsors want information structured in forms, but they need flexibility."

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