CDISC and NORD to Develop Data Standards for Rare Disease

Nonprofit advanced data standards developer CDISC and the National Organization for Rare Disorders have entered a partnership to develop global data standards for rare diseases.

Photo: Pamela Gavin, NORD executive vice president and chief operating officer

The organizations said the data standards will be released in a Therapeutic Area User Guide that will be available at no cost on the CDISC website for researchers to leverage in studies to maximize data’s full potential.

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards. 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. The standards are required by the United States Food and Drug Administration, Japan’s Pharmaceuticals and Medical Devices Agency, recommended by the China National Medical Products Administration (NMPA), and adopted by the world’s leading research organizations.

Therapeutic Area User Guides provide examples and guidance on implementing CDISC standards so that data can be structured effectively and easily analyzed. CDISC standards drive operational efficiencies within the organizations that use them, expedite the regulatory review process, and reduce time to market for treatments developed based on patient data. To date, CDISC has developed Therapeutic Area User Guides for more than 40 disease areas.

“We believe that by partnering with CDISC, we can help set global data standards that will lead to greater participation in research and fuel a new era of patient-centered innovation,” said Pamela Gavin, NORD executive vice president and chief operating officer.

Author: Rare Daily Staff