How to Make Progress with Electronic Data Capture, Current and Future Status of EDC in Europe

Andy Richardson, Zenetar Ltd; Case Study: Use of EDC at Boehringer Ingelheim, Stephane Collet, Boeringer Ingelheim, Andrew Cooper, Oracle Corp.;

Perceptions of the EDC and Web-based trials in CEE, Peter Heger, Health Research Services, Ltd.

The challenges that exist in Europe are similar to the US, senior management commitment to the use of EDC and appropriate user process and software functionality training. However, in Europe there is a need for a scalable multilingual deployment and support model, there still remains a lack of regulatory direction, and an absence of data interchange standards for investigational site collection - some of those involved in the data collections area may change the standards slightly to meet their needs and thus create a variability in the data collection requirements. Boeringer Ingelheim reported on a successful partnership with both Oracle and HP in using EDC. They reported substantial speed and cost benefits over paper and in house training was reduced through a familiar study design tool-they had used it elsewhere and it was familiar to everyone, so learning the new tool was not difficult. Regarding the CEE survey, investigators and clinical research staff felt that EDC tools are improving the investigators' ability to find and manage patients, but their expectations about tools to find and manage patients are much higher than what the reality of the situation shows.