Today CDISC and Microsoft co-hosted a virtual workshop to shape the future of standards and technology by planning the next generation CDISC Library. The CDISC Library metadata repository serves as the single, trusted, authoritative source of CDISC standards metadata for the clinical research community.
"CDISC is excited to collaborate with Microsoft on this important next step, which will set the pace globally for clinical innovation regarding standardized data," said David R. Bobbitt, President and CEO, CDISC. "Our collective work is mission-critical for global health-a lesson that the COVID-19 pandemic has brought home like never before. In order for clinical research data standardization to be more useable and effective, this global community must take even greater advantage of technology."
Paul Slater, Life Sciences CTO and Co-Founder of the Clinical Research Innovation Hub at Microsoft said, "Microsoft is committing significant talent and resources to this effort as a key component of our dedication to transforming clinical research trials. We see in the CDISC community a passion for collaboration and solving real problems that complements Microsoft's mission."
With the support of Microsoft as well as the broader clinical data standards community, the new CDISC Library will deliver a "freemium" model, allowing academic researchers and non-members to access a basic version of CDISC Library at no charge. CDISC and our partners are committed to making the adoption and use of CDISC standards as seamless as possible to support academic users in driving more meaningful and efficient research.
"We look forward to our community leveraging a more flexible, scalable, and modernized suite of technology solutions," added Dr. Sam Hume, Vice President, Data Science, CDISC. "The next generation CDISC Library will provide machine-readable standards, standardized mapping to other data standards, and serve as a tool for community curation of standards that support data becoming accessible across geographies and disciplines, interoperable across systems and studies, and reusable for research today and tomorrow."
The workshop was opened by Dr. Ülo Palm, a member of the CDISC 360 Advisory Committee and former TransCelerate BioPharma, Inc. Corporate Secretary, and Chair of the Clinical Oversight Committee who made the case for change. Dr. Palm described "industry-wide challenges" that require an industry-wide set of solutions. He went on to state, "We have seen how effective our entire industry can be when we work together."
Mr. Bobbitt thanked TransCelerate BioPharma and Dr. Palm for their long-time commitment and support: "TransCelerate members invested early and significantly in metadata repository technology at CDISC beginning in 2013, frankly at a juncture when others were wary of investing. The next generation CDISC Library and our collaboration with Microsoft are a direct result of the commitment TransCelerate has made to quality data standards and technology-based innovation."
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), recommended by the China National Medical Products Administration (NMPA) 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
Ann P. White