This course offers an in-depth introduction to the foundational principles of clinical research, situating them within the broader framework of drug, biologic, an medical device development. Participants will examine the regulatory, scientific, and ethical underpinnings of clinical trials, with particular emphasis on the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines as the global standard for trial conduct.

Key topics include the structure of the drug development pipeline, trial phases (I–IV), and essential methodological concepts such as study design, randomization, blinding, and endpoint selection. The course also explores the ethical frameworks guiding research with human participants, including informed consent, risk benefit assessment, and protection of vulnerable populations. Case examples from pharmaceutical and medical device trials will be used to illustrate how these principles are applied in practice.

By the conclusion of the course, participants will have developed a comprehensive overview of the clinical research process, enabling them to explain the scientific rationale, operational requirements, and regulatory obligations that govern the design and execution of modern clinical trials across therapeutic areas.