The long-awaited move toward risk-based monitoring has started. Having introduced its partial source document verification (PSDV) offering back in 2010, Medidata ($MDSO) has now reported a 50% year-on-year jump in the number of clients using the technology.
PSDV allows clinical trial sponsors to cut the time their study monitors spend verifying documents at research sites. On-site SDV was considered a vital component of good clinical practice, but studies in recent years have questioned its necessity, particularly now data are captured electronically. Big Pharma consortium TransCelerate BioPharma and Medidata have collaboratively led the charge toward risk-based monitoring over the past year and their actions appear to be having an impact.
Medidata reported a 50% increase in PSDV clients last year. The rapid uptick comes off a low base but could continue for some time. "There is literally zero penetration relative to the size of the market opportunity," Medidata CEO Tarek Sherif said on the company's fourth quarter results conference call. The move away from 100% SDV is good news for Medidata as it searches for fast-growing fields to supplement its core, maturing electronic data capture (EDC) offering.
Clinical trial sponsors could also benefit. SDV is an expensive, time-consuming element of the clinical research process--a Swedish study from 2009 found it accounts for one-third of the total budget of the average Phase III trial--and the return on investment for sponsors is questionable.
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- and the call transcript