Electronic Data Capture

Electronic data capture (EDC) tools provide automated support for data collection, reporting, query resolution, randomization, and validation, among other features, for clinical trials. There is a trend toward greater adoption of EDC tools in clinical trials, but there is also uncertainty about how many trials are actually using this technology in practice. A systematic review of EDC adoption surveys conducted up to 2007 concluded that only 20% of trials are using EDC systems, but previous surveys had weaknesses.

So now-a-days emphasis is placed on technology solutions such as Electronic Data Capture (EDC) to control operational costs and expedite time-to-market. By capturing data electronically, and storing the data in advanced databases, key clinical constituents-investigators, sponsors, research organizations and regulatory agencies-can gain access and visibility into study data sooner for earlier insight into the conduct of studies.

Paradigm Solution to Electronic Data Capture

Paradigm has worked closely with Medidata on their RAVE™ product line. Every implementation of a RAVE™ requires it to be configured as per the client?s specific Data Management Plan (DMP) provided for every research trail. Business rules for a trial are implemented using the Edit checks that are built as per the Data Management Plan. The complex business rules are created using Custom Edit checks. Paradigm has been involved in developing these custom edit check procedure creation and unit testing. Apart from these, Paradigm has also been involved in creating custom scripts for modifying the data and resolving some of the production issues related to Custom Edit checks.