Understanding 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.
With a focus on the US regulatory environment, Novella Clinical explains how these variances can impact clinical trial processes.
- Device Classification
- Clinical Study Types
- Study Design
- Defining Endpoints
- Regulatory Considerations
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