Certificate - Clinical Trials Design and Management

Learn from leaders in the global biopharmaceutical and medical device industries who are discovering new treatments and health products every day. You will gain a solid and practical understanding of the entire clinical trials process—from drug and device development to monitoring—and gain a foundation in the scientific principles, current regulations, and ethical issues involved in clinical research. 

Clinical Trials Design and Management certificate program objectives 

• Understand and apply Good Clinical Practices (GCP)
• Distinguish regulatory requirements and differentiate between regulations, guidelines, policies and standard operating procedures (SOP)
• Identify the roles, responsibilities, interactions and concerns of study site personnel
• Use coding dictionaries such as MedDRA® and WHO-Drug for adverse event reporting
• Prepare clinical trial reports, summaries and other documentation
• Understand clinical trials designs, management, and approval objectives for drug and device development.
• For successful interactions with clinical sites, investigators, regulators, contract research organizations, and sponsor management.
• Understand the use of statistics in designing clinical trials and analysis of results.

Important: Kindly note that while this program requires a degree for admission, it is still considered an Undergraduate level program.