Web EDC - a backwards "solution" to a straight-forward problem

Posted on Oct 2, 2009

From the current issue of Bio-IT World comes yet another report on the growing frustration with EDC systems and their failure to deliver on promised efficiencies: ”Of all the e-clinical technologies, electronic data capture causes the most site frustration…Today’s EDC systems create more rather than less work and expense.”

Technology is not a silver bullet, and installing new technology on top of existing processes not optimized to support that technology only makes matters worse, not better. A mass-market EDC system is necessarily a complex, one-size-fits-all solution that cuts across the grain of existing processes and working practices. And these systems are unable to effect process optimization or standardization because there is too much variation at the site level and too many EDC systems cutting the grain from different angles.

Rather than build a solution and then look for the problem, we must begin with the problem to determine the best technological solution. EDC vendors are smart enough to figure that out, of course, but a one-size-fits-all solution is not flexible enough to address local needs. The solution might be an EDC system customized to local needs—something a CRO with a third-party EDC can not do. Or the solution might be a digital pen that meshes nicely with the working practices of healthcare professionals not interested in data entry. Or it could even be paper, or a combination of technologies on a global study.

The jury is still out on mass-market EDC but localization and simplicity and flexibility are strong currents running in the opposite direction.

                                                           - Maurice Hagar, PMP, Chief Information Officer at Health Decisions