Electronic data capture technology is giving way to the e-clinical ecosystem. Alan Louie, research director at IDC Health Insights, says that Phase III clinical trials are now fairly well saturated with EDC products, and Phase II is rapidly being penetrated. Phases I and IV will follow, in part because the business case for EDC in these stages is less clear-cut.
Louie projects U.S. EDC revenue of $568 million for 2010. He spoke at the recent Life Sciences Technology Insight conference in Boston.
All in all, it's good news for sponsors and CROS. EDC price pressure is "pushing south," he says, as products become commodities. Exception: those purchased for use in Phase III studies. The lower tolerance for risk at this phase motivates those anxious to minimize any risk to data to pay a premium.
With saturation, EDC is giving way to e-clinical software suites, which will feature increasing interconnection over time. Standards are helping to enable interoperability but custom integration is still required, he says.
Suites are nonetheless becoming more comprehensive. He expects the thinking among some drug developers to become, "let the e-solution vendors keep up with the regulatory burden in their product suites, while I focus on my core drug development competency."
Among current systems developed, he cites as forerunners the Outlook-based Transenda, which provides users a familiar front end. The Medidata Safety Gateway, an EDC-to-safety-system interface for the company's Rave system, also simplifies data entry, he says. Louie says he expects more options along these lines.
- see details of the Transenda and Medidata systems