AUSTIN, Texas–(BUSINESS WIRE)–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.”
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
Ann P. White, +1-512-363-5826