Analytical Methods for Regulat
This course will give the student the fundamental knowledge of statistical concepts and analytical methods as applied to biomedical science and clinical trials. It will emphasize basic concepts of methodology and experimental design, quantitative analysis of data and statistical significance. A case study approach will be used to cover the basic designs of clinical trials with emphasis on appropriate methodologies, endpoint variables, control groups, blinded studies, eligibility criteria and placebo control. The course will cover statistical analysis including probabilities and variables. Students will be required to design and implement a full protocol for a fictitious drug or medical device elucidating the data for approval.
- Understand basic computational statistics.
- Understand basic clinical trial design.
- Understand the concepts of randomizing and blinding.
- Understand basic clinical trial methodology.
- Classify various types of clinical trials.
- Analyze final data.
- Analyze interim data.
- Develop sample size for a clinical trial.
- Evaluate efficacy of a clinical trial product.
- Evaluate safety data of a clinical trial.
- Manage data from a clinical trial.
- Development and implement a full scale clinical trial protocol with emphasis on data management and analysis.
Why Choose National University?
We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 200,000 alumni worldwide.
Focus on one subject at a time — one month at a time — and finish your degree faster.
75+ Degree Programs
Choose from associate, bachelor’s, and master’s degrees, plus credentials and certificates.
On Campus or Online
Study when and where it’s convenient for you with evening, weekend, and 100% online classes.
Apply or transfer any time. Classes start monthly, and applications are accepted year round.
Attend class and learn onsite at one of over 20 locations in California.
As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.