Learn the nuances of ensuring your site is prepared for conducting investigative device clinical trials, as experts from both sponsor/CRO and site perspectives discuss:

• The roles and responsibilities the FDA and CMS play in getting a trial approved to begin
• Differences between category A & B devices, and how pricing is determined for category B device procurement by Site
• Considerations for sites within the study budget negotiation for device trials
• Compliance considerations for research billing, and how categories A and B can differ
• Unexpected or atypical scenarios that can arise…and how to handle them!