SYS-CON MEDIA Authors: Pat Romanski, Gary Arora, Zakia Bouachraoui, Yeshim Deniz, Liz McMillan

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CDISC U.S. Interchange Serves as Spotlight for New Initiatives and New Look

CDISC wrapped up its 15th annual U.S. conference in Bethesda, MD, where attendees were the first to hear about a number of new initiatives as well as participate in active discussions with regulators including representatives of U.S. FDA and Japan PMDA. CDISC Interchanges are global events held annually on three continents with hundreds of attendees gathering to network, share their expertise, best practices, and lessons learned about implementing CDISC standards to bring clarity to clinical research data.

The conference featured a variety of experts, including keynote speakers Dr. Atul Butte, Priscilla Chan and Mark Zuckerberg Distinguished Professor at the University of California San Francisco, who addressed the rapidly unfolding future of clinical research and health informatics and Jonathan Chainey, Global Head of Data Standards and PD Biometrics at Roche, who shared practical issues of utilizing CDISC standards in the real world.

Peter Van Reusel, CDISC’s Chief of Standards, introduced the CDISC Proof of Concept, a project that will demonstrate the feasibility of standards-based, metadata-driven automation as a start toward realizing the primary benefits expected of CDISC standards. Conference attendees agreed that the Proof of Concept would substantially improve efficiency, consistency, and re-usability across the clinical research data lifecycle. Van Reusel announced the formation of a working group to plan for the Proof of Concept.

Regulators from around the world were also present to answer attendees’ questions about submissions and participate in roundtable discussions.

“This Interchange was a strong culmination to a very positive year for our community,” commented David R. Bobbitt, CDISC President and CEO, who updated the organization's strategic plan priorities and revealed the new look, messaging, website and multimedia tools of CDISC’s new brand during the Interchange’s opening plenary. “Our global community continues to awe and inspire me as we work together to amplify data’s impact and solve issues too complex for any one individual, team, or organization to address alone. It is indeed a new day at CDISC.”

About CDISC

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org

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