This 90-minute course introduces the drug development process through the lens of ICH E8(R1) and ICH E6(R3), helping you understand how development plans, trial objectives, and quality-focused decision-making align across the clinical development lifecycle. You’ll explore how risk-proportionate, quality-by-design approaches—and Critical-to-Quality (CtQ) thinking—support participant safety, reliable results, and operational feasibility in real-world clinical research.
This self‑paced course introduces the core concepts, models, and terminology associated with DCTs, with a strong emphasis on the principles outlined in ICH E6(R3).
This course introduces the essential components of a modern, risk-based Quality Management System (QMS) and reflects the updated expectations outlined in ICH E6(R3).
This course provides a clear, practical walkthrough of the full adverse event (AE) reporting cycle—what must be reported, why it matters, and how responsibilities are shared across site, sponsor, and service provider teams. Updated with the latest principles from ICH E6(R3) and aligned with ICH E2A.
This course introduces the essential metrics that every site should track to strengthen recruitment, accrual, and retention in alignment with ICH E6(R3) expectations.