The CDISC Europe Foundation (CEF) assists CDISC in meeting the needs of our Europe-based members by offering support and participation in projects and events taking place throughout the continent. The CEF qualifies as an EU Research Organization.
The CEF:
- Leads the development of standards that improve efficiency while supporting the scientific nature of clinical research, regulated and unregulated.
- Recognizes the ultimate goal of creating regulatory submissions that allow for flexibility in scientific content and are easily interpreted, understood, and navigated by regulatory reviewers.
- Acknowledges that the data content, structure and quality of the standard data models are of paramount importance, independent of implementation strategy and platform.
- Maintains a global, multidisciplinary, cross-functional composition for CDISC and its working groups.
- Works with other professional groups to encourage that there is maximum sharing of information and minimum duplication of efforts.
- Provides educational programs on CDISC standards, models, values and benefits.
- Accomplishes the CDISC goals and mission without promoting any individual vendor or organization.
The CEF carries out research and development in the following areas:
- Technology, in particular developing global data interchange standards for biopharmaceutical research, integration profiles and process redesign to speed research studies
- Standards and models of therapeutic areas to research into new therapies for various diseases
- Methods to enable the use of electronic health records for research purposes