This course offers an introduction to common clinical research and analytical methodologies used in device and pharmaceutical product development. Specific topics include proof of concept and technology development surrounding device feasibility studies, exploration of new applications, indications and modification methods, and safety and effectiveness. Also included are human factors engineering, medical personnel usability, and over-the-counter, home-use, or direct-to-consumer products demonstration of clinical value, and qualifications for reimbursement. The student learns the specific methods for different products and applications, such as, pharmaceuticals, biologics processing (e.g., blood processing), in vitro diagnostics, clinical laboratory instruments, and monitoring, diagnostic, therapeutic, or preventive devices. Factors in the design of clinical research methods include: -statistical methods and power analysis, quantitative versus qualitative methods protocol design, and inclusion/exclusion criteria -selection of study sites and investigators, including the choice of foreign or domestic sites -regulatory and ethical restrictions Prerequisites: RA 601 and RA 602A. It is recommended that RA 609 be taken before RA 608.