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 course equips clinical research professionals with practical strategies to evaluate recruitment pathways, identify barriers to participation, and implement thoughtful improvements grounded in ICH E6(R3) principles.
Learn the essentials of clinical trials and the global standards that govern them. This 90-minute online course provides a clear, structured introduction to the process, roles, and guidelines that ensure ethical and effective research.
This interactive course offers a clear, practical approach to understanding and applying ICH E6(R3) principles in clinical trial protocol development and review.
With the release of ICH E6(R3), expectations around quality, flexibility, and data integrity have evolved—placing greater emphasis on risk-based approaches, patient-centricity, and digital enablement.