Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Learn the Scientific, Ethical, Practical, Regulatory, and Economic Concepts of Clinical Trials
This program combines business principles, an understanding of the good clinical research practices, and skills necessary for navigating the changing political, regulatory, and financial landscapes.
Overview of Clinical Research
- Overview of drug development
- Clinical statistics for no statisticians
- Clinical project management
- Development of a clinical study report
- Art of writing a clinical overview
- Oversight of clinical monitoring: trends and strategies
Objectives of the course are:
- To be aware of the ethical issues involved in human subjects research;
- To become familiar with the roles and responsibilities of the principal investigator and the institution when conducting clinical research in Innovin IT Solutions;
- To have an understanding of Food and Drug Administration (FDA) oversight of clinical research;
- To become familiar with how developments in science and health are reported by the media and how to work effectively with reporters.