This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.
Recent Tufts CSDD research shows that the cost of clinical trial delays is much lower than previously thought, underscoring the importance of Risk-Based Quality Management (RBQM) and Quality by Design (QbD). Cyntegrity's Johann Proeve, PhD, and Anastasia Shapovalova, MSc, highlight the benefits of a data-driven approach and live process monitoring in enhancing trial efficiency.
Explore the impact of ICH's Q9(R1), Quality Risk Management, guideline on RBQM and clinical trials in our latest blog post. Don't miss our free infographic that simplifies this complex guideline. Enhance your risk strategies today!
Be prepared for ICH E6(R3): turn guidelines into real-world action. In this post, we delve into the key updates and training gaps.
Unpacking the new ICH guidelines, E6(R3) and E8(R1), we illuminate their key elements, identify gaps, and compare the two in terms of their unity, differences, and complementarity.
Clinical trials require a comprehensive approach to ensure quality and efficiency. Quality by Design, Risk-Based Monitoring, and Risk-Based Quality Management work together to achieve these goals, focusing on building quality into the trial process, targeting monitoring activities, and continuously improving trial quality.
With the release of the final ICH E8(R1) version this month, sponsors and CROs are encouraged to embrace a Quality by Design culture. This final paper is part of a more general Good Clinical Practice (GCP) “Renovation” that involves the modernization of ICH E8 and subsequent renovation of ICH E6.
Today we are proud to announce another milestone for our organization. Being ISO certified means that our QMS drives the three key principles of ISO 9001.
The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.
Within the bounds of risk-based quality management, the utilization of predefined Quality Tolerance Limits (QTLs) is a way to control quality and risk in clinical trials. QTLs identify systematic risks to patients and data integrity at the study level. We've listed the 7 most commonly used QTLs that are applicable to most trials.
