Sponsor Survey Gives Nod to ‘Full Service’ EDC


By Deborah Borfitz
Electronic data capture (EDC) is already in widespread use – more so than clinical trials management systems (CTMS), clinical data management systems (CDMS), and even interactive voice response systems (IVRS) – according to results of a recent survey of about 200 sponsor companies.

In the survey, conducted by Phoenix Data Systems (PDS) in partnership with pharmaceutical publication PharmaVOICE, 83 percent of respondents reported that they “currently use EDC,” says Jim Dorsey, director of marketing for PDS. That compares to 64 percent, 58 percent, and 54 percent, respectively, using IVRS, CDMS, and CTMS.

Results of the Web-based survey, conducted in early December 2006, surprised PDS. There’s a possibility that larger sponsor companies, among whom EDC usage is likely higher, were “over weighted” in the survey, says Dorsey. Current users probably also included some EDC dabblers. More than 40 percent of respondents worked for an organization that conducted fewer than 11 clinical trials over the last year.

Another key finding of the survey -- that half of all respondents consider EDC more attractive as an outsourced service than as a technology-only offering -- is the more meaningful number, says Dorsey. It suggests a healthy level of acceptance for the concept of full-service EDC to which PDS ascribes.

While many vendors still focus on “functionality and features,” sponsors no longer need convincing that the technology works, says Dorsey. Survey results show they “now worry about what it really takes to [use eClinical technologies]…as a standard way of doing business.” Ease of use, study build and support services, and vendor experience topped the list of sponsors’ EDC selection criteria. Speed, insight on study progress/results, and accuracy ranked as the most important EDC benefits.

Close to half of survey respondents said that they expect to increase their EDC use by more than 50 percent over the next two years. “We’re entering the phase of operational excellence” when the technology is useful for more than “just EDC” or “just Phase III trials” by big companies, says Dorsey.

Crossing the credibility hurdle “has been a long, hard battle” and resulted in “greater use of derivative technologies,” notes Bill Claypool, MD, CEO of PDS. “Our reporting, data management, and IVR services have really taken off in the last 18 months.”

In terms of bookings, PDS had a “controlled growth rate of 40 percent year over year between 2000 and 2006,” says Claypool. Bookings for the first quarter of 2007 exceeded $5.8 million through 26 new commitments for projects in all trial phases, including four pivotal Phase III studies. This year, with staffing at 100 employees by June – a steady rise from 40 in January 2005 -- “we will greatly exceed that figure.” The company is a “solid player” among second-tier EDC players, behind Medidata and Phase Forward.

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