BIO Online Learning

Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth

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.

bio-course-directory-image-2 (1).png
Clinical Development 301: Phase II/III Course Trailer

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

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

Certificate Requirements

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

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
FLIP

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
Related Courses
FLIP

Do you need to understand the drug development process, including details about a drug's life cycle from its discovery through post-marketing studies?  This is the course for you.

FLIP

The Regulatory Process provides a summary of the regulatory bodies involved in approving both small molecule drugs and biologics.

Professional Certificate
FLIP

Drug Discovery of Biologics explains the steps involved in discovering new biologics, with a special...

Professional Certificate
FLIP

Explains the steps involved in discovering, validating and optimizing new therapeutics.

Professional Certificate