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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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Clinical Development 301: Phase II/III Course Trailer


  • 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

Clinical Development 301 Phase I/II Agenda
Course Price:
$150 USD
BIO Member Price:
$120 USD
Course Length:
55 minutes
Course Level:
Completion Period:
2 weeks
Course Format:

Certificate Requirements

  • View entire course 
  • Pass the course exam with a 70%
  • Complete the course evaluation
Suggested Prerequisites

Clinical Development 101: General Principles sets the stage for the entire clinical development process. Learn who conducts trials, how trials are conducted, and the various regulatory elements that must be performed throughout Phases I-IV trials.

Professional Certificate

Clinical Development 201: Phase I explores the prerequisites, purpose, design, and conduct of Phase I trials. Topics such as bioequivalence, pharmacokinetics, pharmacodynamics, endpoints, selection of dose, and more are explained in detail.

Professional Certificate
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