CSC : CDISC Data Standards and Your Regulatory Submission: It's Time to Implement - Complementary Webinar

CDISC Data Standards and Your Regulatory Submission: It's Time to Implement
Thursday, July 28, 2011, 8:00 am pacific time / 11:00 am eastern time / 13.00 BST

Interchange Standards Consortium (CDISC) data standards for all regulatory applications delivered to the agency. In fact, on July 21, 2004, the FDA issued a press release announcing that the CDISC Study Data Tabulation Model (SDTM) was the preferred method for submission of source data to the Center for Drug Evaluation and Research (CDER).1 Analysis data used in the clinical statistical review also is being standardized, and CDISC released the Analysis Data Model (ADaM) implementation guide V1.0 in late 2009. The ramifications of these data standards are far-reaching for sponsors. The FDA is now considering a rule change that would mandate the submission of data in these standard formats for all new marketing applications. In addition to the FDA, other government organizations such as the National Cancer Institute and the National Institutes of Health actively incorporating these standards. Unfortunately, even in 2011, only a very small percentage of sponsors are developing and submitting the SDTM and ADaM.

Trend and Opportunities

In this informative and complimentary Webinar, CSC subject-matter expert Gregory Ridge will discuss CDISC's history, the FDA's usage of data standards and sponsor implementation strategies across both the SDTM and ADaM. The conversion of legacy source data to CDISC data standards is a costly proposition in terms of time and resources. Topics included will be the development of a submission data plan and gaining an understanding of the source-to-CDISC conversion process. The discussion will also focus on development of the supportive metadata required in a CDISC submission, commonly called the define.xml.

Key Learnings

Industry Trends: Learn about the history of CDISC and how its standards are utilized at the FDA. Examine the most current metrics on how sponsors are dealing with migration to CDISC and how partner organizations can assist in the development and validation of a company's submission package.

Success Factors: Understand the process of conversion of legacy source data to CDISC models. Discover what's required to migrate a company's submission data package from legacy to state of the art.

Risk and Reward: Determine the strategy that best suits a company's data submission needs. Recognize the current regulatory landscape, and develop a submission plan that best mitigates the company's risks.

A Complete Solution: Learn about all of the components of an electronic submission and how they integrate with a company's dossier. Understand the challenges that must be met to develop a CDISC data package, and learn the costs - in terms of both financing and resources - associated with it.


About the Presenter

Gregory Ridge is group leader of the Regulatory Data Standards and Integration organization at CSC. He has 20 years of pharmaceutical programming experience. His CSC team has developed multiple successful CDISC data packages for clients in a variety of therapeutic areas. Prior to joining CSC, Greg was associate director of clinical programming at sanofi-aventis for 14 years, leading the oncology and cardiovascular therapeutic areas. His teams successfully submitted nine CDISC-compliant submissions to the FDA by utilizing multiple release versions of the SDTM and ADaM.

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