Monday, October 4, 2010

Overview on CDISC Implementation

CDISC Advantages

CDISC has developed a set of data standards to enhance

data collection,
analysis, and
reporting efficiencies,
improve safety monitoring, and
streamline the review and approval process for investigational treatments.

Under the ICH’s electronic Common Technical Document (eCTD) guidance, CDISC Study Data Tabulation Model (SDTM) is the preferred standard for content format and structure of clinical data for all clinical studies. Based on proposed federal regulations, the FDA will mandate that all clinical trial submissions be in electronic format and that the content comply with data standards guidance. Veristat helps our clients by not only implementing these standards on a project or program, but also by providing our clients with an understanding of the CDISC standards.