The Business of Clinical Research

3 units

An overview of the business elements of clinical research, this course covers drug and device development, the regulatory environment, finance, corporate structures, and the clinical trials office. Students will consider stakeholders including pharmaceutical and device industries, academic and private research centers, government agencies such as the National Institutes of Health, nonprofit agencies and a variety of other organizations such as American Diabetes Association and the National Cancer Institute. They also will study local, state, and federal regulations, as well as international and global issues that impact the business of clinical research.