SAS poised to help life sciences firms implement CDISC data models
Today at the joint CDISC and DIA conference “e-Clinical Interchange: From Clinician to Submission,” SAS, the leader in business intelligence, outlined the company’s capabilities for helping its pharmaceutical clients adopt the CDISC Study Data Tabulation Model (SDTM) used in submitting human drug clinical trials data to the U.S. Food and Drug Administration (FDA). SAS is providing demonstrations of these capabilities to conference attendees this week.
Developed by the Clinical Data Interchange Standards Consortium (CDISC) and announced as a standard by the FDA on July 21, SDTM will accelerate research by allowing FDA reviewers to drastically reduce the amount of time spent reorganizing clinical trials data traditionally submitted in a wide variety of formats. Through the use of a standardized data format, FDA reviewers will be able to evaluate data more quickly and effectively, accelerating the review of therapies submitted to the agency for approval.
“With the announcement of SDTM, the FDA is encouraging pharmaceutical companies to submit clinical trials data in a format that will expedite the clinical research conduct, review and approval cycles,” said Laurie Rose, director of health and life sciences global strategy for SAS. “SAS has been closely involved in the development of the CDISC standards, and we have technology available today to support pharmaceutical companies in their implementation of the new data models.”
SAS has been the de facto standard for data transformation and analysis in the life sciences research industries for many years, and the required FDA data submission standard since 1999. That year, the FDA adopted the SAS transport format as the standard for delivering data for FDA submissions, and the agency will still use this standard for the foreseeable future. Anticipating the movement of the life sciences industry and its governing regulatory bodies toward the new standards, SAS has developed technology available today to support the emerging CDISC data models.
The CDISC models represent a joint effort by government, academia and the life sciences industry to quicken the pace of research through the use of standards and health information technology. In addition, the FDA’s adoption of the SDTM standard supports the agency’s commitment to the Critical Path initiative by helping to automate the largely paper-based clinical trials research process and promoting easier communication and collaboration among clinical researchers.
The SDTM standard also presents an incentive for life sciences research firms to adopt other CDISC standards, such as the Operational Data Model (ODM), Analysis Data Model (ADaM) and Laboratory Model (LAB). By using these standards, life sciences firms can expedite data processing efforts and reduce the costs of bringing medications to market.
“SAS has played a prominent role in supporting CDISC’s efforts to develop vendor-neutral standards for the medical and biopharmaceutical community,” said Rebecca Kush, Ph.D., president of CDISC. “SAS already offers the technology that will help the industry put CDISC standards, including the ODM and SDTM, into practice.”
SAS has a deep commitment to the development of data standards in the pharmaceutical industry in general and to CDISC in particular. Dr. Edward Helton, the company’s chief strategist of regulatory and biomedical affairs, serves on the board of directors for CDISC. SAS also supports CDISC as a corporate sponsor, and David Handelsman, SAS clinical research and development strategist, serves as a member of CDISC’s Industry Advisory Board. This group provides support for CDISC’s strategic direction by organizing advisory meetings, participating in working teams and task forces, supporting the strategic plan, assisting in fundraising and enhancing the organization’s public image.
For more information on the FDA announcement on SDTM, see: http://www.fda.gov/bbs/topics/news/2004/NEW01095.html
About SAS
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