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Clinical Data Interchange Standards Consortium (CDISC)

Overview: The Clinical Data Interchange Standards Consortium (CDISC) develops industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to develop independent standards to improve data quality and to accelerate product development in the medical and biopharmaceutical industries. CDISC has outlined key objectives to help define its work, including: leading the development of standard data models that improve process efficiency while supporting the scientific nature of clinical research; recognizing the ultimate goal of creating regulatory submissions that allow for flexibility in scientific content and that can be interpreted, understood, and navigated by regulatory reviewers; acknowledging that the data content, structure and quality of the standard data models are of paramount importance, independent of implementation strategy and platform; maintaining a global, multidisciplinary, cross-functional composition for CDISC and its working groups; working with other professional groups to encourage sharing of information and minimal duplication of efforts; providing educational programs on CDISC standards, models, values and benefits; and accomplishing the CDISC goals and mission without promoting any individual vendor or organization.

Specifications: Not available

IPR Policy: Not available

Current Status: Active

Last Updated: June 3, 2014


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