Over the past decade, CDISC data standards have become the FDA preferred method for the data submission. In fact, the FDA is considering a proposed rule change that would mandate the submission of data in CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) formats for all new marketing applications. However, the implementation of this standard has proved to be intimidating to many with only a very small percentage of drug companies actually developing and submitting data in this format.
During the webinar, Thomas Kalfas, an experienced data management professional and CDISC subject matter expert, shared his knowledge and strategies for implementing CDSIC. Topics included a brief review of CDISC, implementation challenges, and insight into the best timing for implementation.