Electronic data capture (EDC) for clinical trials has been around in one form or another for a number of years, with the technology continuously evolving over this time. Although low volume or pilot usage of EDC does not yield the full benefit of this technology, increasing confidence in the technology together with the operational benefits highlighted by some companies (1) is leading most companies to set EDC adoption targets, with 60 to 90 per cent of new study starts by 2006 not being atypical (2). Because full ROI on EDC usage is not realised until EDC is the default means of running a clinical trial, breaking out of low volume or pilot usage of EDC frequently requires a leap of faith.
As more companies take the strategic decision to scale their use of EDC, the EDC life cycle will move from its current position where it is really only the early adopters that are taking full advantage of the benefits of the technology. In addition to the leap of faith, a strategy and plan are required in order to effectively overcome the inertia caused by the existing organisation and application set. Processes, organisation and technology should be included in the strategy for scale up. EDC software selection directly affects (or is affected by) the technology strategy. The software selected, in turn, will have an impact on processes, organisation, logistic and training strategies.