Determining Return on Investment, the ultimate measure of success when implementing Electronic Data Capture (EDC), requires the consideration of many factors, both quantitative and qualitative. Study startup time, data handling costs, end user satisfaction, and reduction in time to database lock are all examples of the components contributing to the actual ROI achieved with EDC. These metrics alone, however, do not provide insight into the degree to which an organization has taken full advantage of the potential offered by currently available technology combined and by intelligent reengineering of trial processes around EDC. Simply put, without first defining the current maximum benefit from EDC, one has no yardstick against which success can be judged.
Time to database lock, the interval between the last clinical visit and when all EDC system deliverables are finalized and approved, is a critical metric when calculating the value of EDC. Although many legacy technologies have promised faster study closure, few if any have delivered it. Therefore, time to database lock provides an ideal target for thought experiments aimed at defining the full potential of EDC.
