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Showing posts with the label CDISC Standards

CDISC and SAS

Why is the adoption of the CDISC standards important for the life sciences industry and what is SAS' relationship with CDISC? A: The Clinical Data Interchange Standards Consortium (CDISC) is fundamentally changing the way information is being managed in the life sciences research industries, and is beginning to change the way the US Food and Drug Administration (FDA) reviews new drug applications. Historically, most pharmaceutical organizations developed their own internal data standards, and associated processing, for managing research information. Each organization's unique approach to this information management process has done little to expedite the overall new drug development process, and in many ways has slowed it down - by requiring each organization to spend unnecessary effort acquiring, developing and implementing distinct processes. Furthermore, the submission of research data in nonstandardized formats makes it difficult for the FDA to develop standard, efficient, ...