Electronic Data Capture

An Electronic Data Capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are now widely adopted by pharmaceutical companies and clinical research organizations (CRO) around the world.

Typically, EDC systems provide:

• a graphical user interface component for data entry
• a validation component to check user data
• a reporting tool for analysis of the collected data

EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance, although some EDC system's such as SciAn Services edcpro are specialized to include tools for phases I-II.

EDC can increase the data accuracy and decrease the time to collect data for studies of drugs and medical devices. The trade-off that many drug developers encounter with deploying an EDC system to support their drug development is that there is a relatively high start-up process, followed by significant benefits over the duration of the trial. As a result, for an EDC to be economical the saving over the life of the trial must be greater than the set-up costs. This is often aggravated by two conditions: 1) that initial design of the study in EDC does not facilitate the decrease in costs over the life of the study due to poor planning or inexperience with EDC deployment; and 2) initial set-up costs are higher than anticipated due to initial design of the study in EDC due to poor planning or experience with EDC deployment. The net effect is to increase both the cost and risk to the study with insignificant benefits. However, with the maturation of today’s EDC solutions, such as Oracle Remote Data Capture (RDC) and OmniComm Systems’ TrialMaster EDC, ClinionTM much of the earlier burdens for study design and set-up have been alleviated through progressive technologies that allow for point-and-click, and drag-and-drop design modules. With little to no programming required, and reusability from global libraries and standardized forms such as CDISC’s CDASH, deploying EDC can now rival the paper processes in terms of study start-up time. As a result, even the earlier phase studies have begun to adopt EDC technology.