5/13/2019

Many people automatically think about drugs when they visualize clinical trials, especially if that has been their experience. Medical devices are essential for human health and it is important to understand how they are distinct from drugs. Although there are similarities, there are quite a few differences between medical device and drug or biologic clinical trials, including:

Safety reporting
Patient populations
Trial design
Regulatory pathways
Post market surveillance

Applicable to all in the clinical research industry, our Drug vs. Medical Device: Comparing and Contrasting interactive eLearning course will provide you with knowledge you can apply with real-life industry examples and scenarios. Included are knowledge checks, a post assessment, and a certificate of completion.

Content includes important differences between medical device and drug clinical trials, including:

Key definitions
Regulatory approval and application processes
FDA Divisions and the global influence of CIOMS, and how they relate to drug and device studies
Major differences in safety reporting, IRB duties, and oversight

Understanding the similarities and differences between medical device and drug clinical trials can support a successful trial outcome. Watch an interactive demo here to learn more. To purchase the full course, visit our store here.

- The Clinical Pathways Team

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