New to CDISC - BioPharma


CDISC works closely with pharmaceutical organizations around the globe to develop high-quality standards that ensure compliance with regulatory guidelines and create clarity in clinical research.  As we evolve alongside the rapidly changing research landscape and welcomes new opportunities for innovation, we will continue to facilitate open, transparent communication about upcoming developments, provide educational opportunities to ensure the use of CDISC standards is as seamless as possible, and strive to make our standards even more beneficial for pharmaceutical organizations around the world.

  • Quality standards: For over 20 years, we've taken a rigorous approach to developing and advancing data standards for clinical research and beyond. Each standard is informed and shaped by the expertise of those at the forefront of research today, making them not just of the highest quality, but also attuned to the practicalities you encounter as you implement them.
  • Greater efficiencies: CDISC standards are recognized and required by leading regulatory agencies (US FDA and Japan PMDA) around the world. Not only do our standards drive operational efficiencies within the organizations that use them, they also expedite the regulatory review process and reduce time to market.
  • Focus on breakthroughs: Researchers spend a substantial amount of time deciphering, translating, and mapping unstandardized data. Implementing CDISC standards means that data can be structured effectively and easily analyzed, leaving more time to focus on discoveries that will have invaluable impact on clinical research and global health.

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.