Clinical Development 301: Phase II/III

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • Course Run Time: 55 minutes
  • Course Level: Level 3 - Advanced
  • Completion Period: 2 week

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.

Suggested Prerequisites

Clinical Development 101: General Principles
Clinical Development 201: Phase I 

Takeaways
  1. Key differences between early stage (Phase I) and late-stage (Phase II/III) clinical trials.
  2. Regulatory significance of clinical endpoint, primary endpoint, secondary endpoint, surrogate endpoint.
  3. Fluency in Phase II and Phase III clinical trial nuances.
  4. Basic statistical analysis completed in late-stage trials.
  5. Description of specialized and expedited development cycles for rare disease, orphan drugs, and therapies for unmet medical needs.
Certificate Requirements
  • View entire course 
  • Pass the course exam with a 70%
  • Complete the course evaluation
Trailer
Viewing Course Materials
Section 1: Phase II/III Introduction
Identifies the principle elements of a well-controlled Phase I/II clinical trial with an in-depth look at study design, endpoints, and statistical ana...More
Section 2: Phase II/III Objective and Design
Compares the general characteristics of Phase II and Phase III clinical trials. Defines pivotal study, adaptive trial, basket trial, and umbrella tria...More
Section 3: Phase II/III Special Designations
Focuses rare disease and serious unmet medical need designations in both the US and Europe. Explains the challenges with clinical studies associated w...More
Final Quiz
Course Evaluation
Certificate Requirements
  • View entire course 
  • Pass the course exam with a 70%
  • Complete the course evaluation
You have two weeks from time of purchase to complete any of the online courses. For example, if you purchase the course at 9 am on Saturday, the course will close at 9 am 14 days later.

Our online classes are between 40 minutes and 85 minutes in length. We suggest allowing 20 minutes to take the end of the course quiz and 10 minutes to complete the class evaluation. 

There are no refunds once you have purchased an online course. 

The online classes are fully animated with a professional voice-over. Each course begin with an overview of what you will learn, the course itself, and then ends with a course quiz to assess your understanding.

You can repeat the class as often as you like within your two week run time.

You have two chances to pass the quiz. A passing score is 70% or higher. 

Each course is to be taken by one individual. If you would like to take our online courses as a group, please contact Stacey Hawkins at This email address is being protected from spambots. You need JavaScript enabled to view it. for pricing.

There are three requirements to receive your course certificate.

  1. You must view the entire course.
  2. You must pass the course quiz with a 70%.
  3. You must complete the course evaluation.

You can download and print your certificate from your dashboard only when all three of these items are completed. 

Before moving on to the next section of our on-demand, online courses, all slides within a section must be viewed.

There is an easy way for you to see which slides you have completed and not completed in the course. Look at the menu on the left side of the course- the slides that have been seen are darkened and the slides that have not been seen are light. 

 

BIO member discounts are available for on-demand, online classes. To access the BIO member discount, use your company email address during the checkout process. The checkout system will automatically recognize your organization and apply the 20% discount to your purchase if your company is a member of BIO. If you use a private email address we are unable to provide you the BIO membership discount.

If your on-demand course expires, but you have not completed it, you can extend it for an additional 2 weeks for $25.

  • Log into your dashboard
  • Go to the on-demand course you want to extend
  • The "Course Extension" button brings you to the payment gateway
  • Please note: It will appear you are being asked to pay the full amount of $150, but a discount will be automatically given once you fill in all of your payment information. 

You have 90 days, from the day your course expires, to take advantage of this nominal extension fee. Once the 90 days are past, you will need to pay the full price to view the course again. 

  1. Once your online course starts click on “Resources” in the upper right-hand corner
  2. In the drop down menu find the link “Course Slides”
  3. Download and/or print 
Certificate Requirements
  • View entire course 
  • Pass the course exam with a 70%
  • Complete the course evaluation