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 widely adopted by pharmaceutical companies and contract research organizations (CRO).

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 in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance.

The trade-off that many drug developers encounter 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.

However, with the maturation of today’s EDC solutions, much of the earlier burdens for study design and set-up have been alleviated through 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.

Medidata Solutions is an American technology company that develops and markets software as a service (SaaS) for clinical trials. These include protocol development, clinical site collaboration and management; randomization and trial supply management.

It allows to capture data from the following sources :

• web forms,
• mobile health (mHealth) devices,
• laboratory reports,
• imaging systems

The company has two primary products.

Medidata Rave EDC, its flagship product, introduced in 2001, is a single system for electronic data capture and clinical data management, allowing client data to be accessible in one place.

Clinical Cloud, introduced in 2013, is a platform used for data capture and management of patient-related data for clinical operations.