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CDISC Europe Foundation

 

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