New to CDISC - Regulatory Agency


Trusted and required by the United States FDA and Japan’s PMDA, CDISC facilitates the review process and expedites approval times for more efficient and effective clinical research. Requiring standardized data enables regulators to modernize the review process with a more consistent use of analysis tools to better view drug data and highlight areas of concern.

  • Clear and consistent data:  Ensuring all data submitted is standardized reaffirms the data you are reviewing is consistent and clear.
  • Expedited treatments to patients:  As we continue our quest for global awareness and adoption of our standards, with your help, we can find ever-better ways to create a shared language that increases visibility into data and brings better, safer drugs to patients more quickly.
  • Quality standards:  For over 20 years, we've taken a rigorous approach to developing and advancing data standards that are open and available for all. Each standard is informed and shaped by the expertise of those at the forefront of clinical research today, making them not just of the highest quality, but also attuned to the practicalities of their implementation.


Learn More:

  • VIEW THE STANDARDS:  The suite of CDISC standards throughout clinical research process.
  • JOIN CDISC:  Over 500 member organizations around the world comprise the CDISC Community.
  • VOLUNTEER: We rely on the subject matter expertise of volunteers to create our standards.
  • TAKE A COURSE:  Public, Private, and Online Training (available 24 hours a day)
  • ATTEND AN INTERCHANGE:  CDISC Interchanges are global events held annually with hundreds of attendees gathering to share their expertise, best practices, and lessons learned about implementing CDISC standards..
  • EXAMINE USES CASES:   Learn how CDISC Standards have been applied in various use cases to bring clarity to data.
  • READ INFORMATION FROM REGULATORS: We regularly post announcements from global regulators.