Clinical Study Requirements: Drugs vs. Devices

Drugs vs DevicesUnderstanding the Key Differences in the Clinical Trial Process

Whether developing a new drug or medical device, designing and running clinical trials can be daunting. How drugs and devices are developed differ dramatically. Study design and regulatory pathways differ; requirements for study sites, end users, training, endpoints and follow up are all variables. This paper examines the key differences and how those impact clinical development with a focus on the US regulatory environment.

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