CDISC Study Data Tabulation Model B. Thompson. We are carefully reviewing the new Study Data Tabulation Model (SDTM) to ensure that our company is doing everything possible to streamline submissions of data to the agency. It should be a goal of companies and the agency to find and implement greater efficiencies to shorten the time to market for important new therapeutics. Dearhammer. Kendle is embracing the new standard format in a variety of ways to ensure the highest quality data management solutions for our customers. Most importantly, we are using CDISC standards as our programming defaults and have trained all relevant programming, statistical, and clinical data management associates on the CDISC standards. Other efforts include working with our customers to accept or adopt CDISC, SDTM, and ADAM (active directory application mode) as their programming standards; working with clinical labs to transfer data using the CDISC LAB model; setting up a global work group with members from all relevant departments to review how well CDISC is working on current projects; and identifying, programming, and validating SAS programs to increase efficiencies. Roy. We are committed to promoting standards and incorporating CDISC data interchange models into the functionality of our product suite. Phase Forward is a CDISC partner and is working closely with the organization. We have developed a CDISC compliant sample study protocol in our Clintrial Clinical Data Management System (CDMS) that can be used to facilitate CDISC compliance. Gregg Dearhammer Kendle International Inc. Kendle is embracing the new standard format in a variety of ways. Most importantly, we are using CDISC standards as our programming defaults and have trained all relevant programming, statistical, and clinical data management associates on the CDISC standards. Kathryn Roy We are committed to promoting standards and incorporating CDISC data interchange models into the functionality of our product suite.

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