BIO Professional Development
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Clinical Development 301: Phase II/III
Clinical Development 301: Phase II/III considers the purpose, design, and conduct of Phase II and III clinical trials. Learn the various trial design approaches, endpoint choices, statistical considerations, and special regulatory designations.
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Takeaways
- Key differences between early stage (Phase I) and late-stage (Phase II/III) clinical trials.
- Regulatory significance of clinical endpoint, primary endpoint, secondary endpoint, surrogate endpoint.
- Fluency in Phase II and Phase III clinical trial nuances.
- Basic statistical analysis completed in late-stage trials.
- Description of specialized and expedited development cycles for rare disease, orphan drugs, and therapies for unmet medical needs.
Download Course Syllabus
Certificate Requirements
- View entire course
- Pass the course exam with a 70%
- Complete the course evaluation
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