CDISC and NORD join forces to develop data standards for rare diseases


DANBURY, Connecticut and AUSTIN, Texas – (BUSINESS WIRE) –CDISC and the National Organization for Rare disorders (NORTH®) announced a partnership to develop global data standards on rare diseases. The data standards will be published in a Therapeutic space user guide which will be available free of charge on the CDISC website for researchers to leverage the studies to maximize the full potential of the data.

According to the FDA, any disease, disorder, illness, or condition affecting fewer than 200,000 people in the United States is considered rare. There are approximately 7,000 rare diseases and it is estimated that 25 to 30 million Americans suffer from rare diseases. Over 90% of rare diseases do not have an FDA approved treatment. Globally, an estimated 350 million people are affected by a rare disease.

Therapeutics User Guides provide examples and guidance on implementing CDISC standards so that data can be structured efficiently and easily analyzed. CDISC standards improve operational efficiency within the organizations that use them, speed up the regulatory review process, and reduce time to market for treatments developed from patient data.

“We are grateful for the opportunity to work with NORD on this much needed initiative,” said Dave Evans, President and CEO of CDISC. “NORD’s support and partnership will allow CDISC to develop standards that facilitate more powerful research, enabling the discovery of new treatments to help patients.”

“We have seen through NORD’s IAMRARE® registry platform the immense value of patient-oriented research to serve as a catalyst for the development of rare disease treatments,” said Pamela Gavin, vice president NORD executive and COO. “We believe that by partnering with CDISC, we can help establish global data standards that will lead to greater participation in research and fuel a new era of patient-centered innovation.”

To date, the CDISC has developed therapeutic area guidelines for more than 40 disease areas.


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

About the National Organization for Rare Diseases (NORD®)

The National Organization for Rare Diseases (NORD) is the leading independent advocacy organization representing all patients and families affected by rare diseases in the United States. NORD started out as a small group of patient advocates who formed a coalition to unite and mobilize support to pass the Orphan Medicines Act 1983. Since then, the organization has led the way in voicing the needs of the community. diseases, by pursuing supportive policies, continuing education, advancing medical research and providing services to patients and families for those who need them most. With more than 330 disease-specific member organizations, more than 15,000 Rare Action Network advocates in all 50 states, and national and global partners, NORD delivers on its mission to improve the lives of people affected by rare diseases. Visit


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