The certificate program is designed to educate students in the area of Clinical Trial Management. Students learn the key aspects of Clinical Trial design and conduct, and have the opportunity to be trained in the fundamentals of Regulatory Affairs. Students will also gain an understanding of the drug development process and have the opportunity to take a business course, such as project management. If a student chooses to continue their studies to pursue the MBS degree with a concentration in Drug Discovery and Development, all credits earned are transferable to the MBS degree, pending approval to the graduate program.

The objectives for the Certificate in Pharmaceutical and Clinical Trials Management include the following:

• Describe the important elements of a well-designed clinical trial
• Design randomized controlled trials and compare the advantages and disadvantages of various clinical trial designs e.g., retrospective, case-control, cohort
• Identify potential sources of bias in clinical trials, and select strategies to eliminate or control for bias
• Apply various biostatistical descriptors and techniques to clinical trial design and use them to interpret results
• Understand the developmental pipeline for small molecule and biological drugs, and the economic aspects of small molecular and biological drug development
• Understand intellectual property and regulatory issues at transitional phases in the development process
• Develop a clear understanding of why ethics are important in clinical research and be familiar with the regulatory practices in place to protect both the researcher and the subject
• Learn about the basic statistical procedures used to analyze data and be able to apply these techniques utilizing a standard statistical package
• Write clinical trial and IRB protocols