This course equips clinical research professionals with practical strategies for preparing for, managing, and responding to regulatory inspections with confidence. Applying ICH GCP E6(R3) principles, learners will explore risk-based quality management, oversight, essential records, data integrity, and quality system practices that support continuous inspection readiness throughout the clinical trial lifecycle.
This webinar introduced the foundational principles of project management in the clinical research environment, with a focus on how these skills show up in day-to-day study operations. Panelists explored key concepts such as scope, timelines, communication, risk, stakeholder alignment, and change management.
This course introduces ICH E6(R3) principles and helps build confidence in managing Essential Records using ALCOA-C+–aligned record management practices. Explore how well-managed records support data integrity, effective Trial Master File (TMF) practices, inspection readiness, and risk-based quality management throughout the trial lifecycle.
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.