Explore the fundamental scientific, ethical, practical, regulatory, historical, and economic principles that support successful clinical trials. Discover the major concepts guiding the design and implementation of clinical trials, and learn to project manage the numerous people and tasks involved at all stages of the process. Enhance your learning with hands-on exercises and real-life examples.
What the Program Covers
- Research design, statistical concepts, and data management
- Ethics in clinical trials including human subjects protection and data integrity
- Roles of governing organizations such as Institutional Review Boards, the Food and Drug Administration, Federal, and non-U.S. authorities
- Life cycle of clinical trials, from research to marketing strategies for drugs and devices
- Relationships between research participants, investigators, sponsors, clinicians, monitors, research coordinators, and regulators
- Management of projects, people, and finances
- Contingency planning and trial follow-up
Benefits
You will learn the essential elements for designing and managing clinical trials. This certificate program may help individuals prepare for professional certification examinations.
Who Should Apply
Level: All Experience Levels
- Individuals interested in entering the field of clinical trials
- Individuals working in any aspect of biomedical research and development for a company or non-profit institution
- Physicians, pharmacists, pharmacy technicians, and laboratory scientists
- Principal investigators (PIs), Clinical research coordinators (CRCs), clinical research associates (CRAs), and project managers
- Professionals in clinical trial data management, site coordination, or on Institutional Review Boards or in companies sponsoring clinical trials
If you have questions about your eligibility for this program, give us a call at 888-469-6499.
