• The medical monitor certification offers a comprehensive overview of the principles of Good Clinical Practice, as well as compliance requirements for ethical and safe medical research.

• This is the only program that provides in-depth training on all aspects of clinical research design and execution, including advanced trial design, randomization, blinding and unblinding; clinical site assessment, preparation, active site monitoring and close-out; and clinical trial protocol development and implementation.

• The medical monitor certification also covers pharmacovigilance concepts crucial to an medical monitor’s role such as AE/SAE identification and tracking; probabilistic assessment of AEs/SAEs as ADRs; risk management in clinical trials.

• Trainees gain working knowledge of financial regulatory compliance: disclosure documentation & updating; FDA audit protocols & strategies.

• An added advantage is its focus on digitized elements such remote data monitoring tools (software & video) ,EDC capture & quality control .