The future of medical device trials is being built on interoperable, high-quality data. In an effort to streamline processes and accelerate innovation, the Medical Device Innovation Consortium (MDIC), in partnership with the Clinical Data Interchange Standards Consortium (CDISC) and the FDA, is leading an initiative to develop data standards for in vitro diagnostic (IVD) devices.
This session, led by clinical data experts, will highlight the significant progress being made. The panel will share key insights from the recently published landscape analysis and discuss:
- Historical challenges and current state for the definition and adoption of standards
- Ongoing efforts between CDISC, FDA, MDIC, and the industry toward the creation of IVD clinical data standards
- What should be done to align global regulatory expectations to simplify the submission and review process
Join us to learn how these standardization efforts are creating an end-to-end harmonized platform that will shape the future of clinical trials for IVDs.
Speakers:
- Carey Smoak, Co-founder and Co-leader of the CDISC Device Team, Roche (retired)
- John Owen, Head, Project Management Office, CDISC
- Nick Decker, Head of Regulatory Policy, Roche
Moderator:
John Acampado, MBA, MPH, PMI-ACP, Sr. Director Clinical Strategy, Veeva Systems
Presented by: MDIC, Veeva, and CDISC
Organized by: Medical Device Innovation Consortium
Language: English