This 90-minute, self-paced course introduces core concepts from ICH E9 and ICH E9(R1) and explores how these principles are applied in practice through the risk-based, quality-focused approach emphasized in ICH E6(R3). Designed for non-statisticians, the course focuses on practical understanding rather than mathematical detail.
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.
Drawing on two multi-stakeholder working group publications, this session examined how deployment models, system fragmentation, and lack of interoperability impact site operations. The webinar introduced a practical framework for measuring eConsent success beyond participant experience.
This webinar explored why community‑driven strategies are critical for improving recruitment and retention in today’s clinical research environment.
In this panel discussion, experienced clinical research professionals explored common ethical dilemmas encountered in day-to-day research operations, including challenges in informed consent, participant safety, protocol deviations, and operational constraints.