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Human Feasibility Clinical Trials: How to Begin and How to Succeed


Michael Otlewski (Clinical Program Scientist, MED Institute)

Location: Tech Theater, Booth 637

Date: Wednesday, February 7

Time: 11:30am - 12:15pm

Pass Type: Expo (Free), Conference (Paid) - Get your pass now!

Free Content & Activities: Tech Theater

Vault Recording: Not Recorded

Human clinical trials are incredibly important, incredibly complex, and incredibly expensive. How do you know when human clinical data are necessary for continued development of a medical device? How do you know what kind of clinical data are needed to answer the outstanding questions and satisfy regulator expectations? How do you collect those data in a cost-effective way that meets the myriad regulations while guaranteeing its trustworthiness and ease of analysis? A contract research organization (CRO) can be an invaluable partner to walk with you through the process and provide expertise based on experience, to mitigate risks and help you efficiently obtain the information needed to move forward with your device.