Monitoring of risks/issues using metrics (KRIs/QTLs) in RBQM is fundamental to the approach and the expectations of regulators, but without critical thinking in their setup, signals may be detected too late to change the course of the study. We will explore the definitions of leading and lagging indicators, look at how the KRI/QTL metric definition impacts how early signals are detected, and why it is important to have the end in mind.

We will build on the concepts of lagging and leading indicators, and consider how each can add value to a cohesive approach to QTL management. With practical worked examples, we aim to illustrate how careful and holistic QTL/KRI definition can help to protect the most critical aspects of your study.

Revision 3 of ICH E6 R3 is an important change for the clinical trial industry, and it is important to highlight the changes and upcoming new ways of working. Sponsors, investigators, CRO representatives, and clinical vendors will gain an understanding of the new regulatory landscape for clinical trial conduct, as well as calibrate processes to align with the release of ICH E6 R3.

In recent years, collaboration within the biotech and pharma sectors has significantly surged. In this presentation, we'll examine the role of open-source tools in fostering collaboration, transparency, and standardisation across industry. We'll also provide an overview of current open-source initiatives in the clinical trial domain, including safety monitoring, data standardisation, and a newly-released open source framework—containing 30k lines of code—for Risk-Based Quality Management (RBQM).

This talk will focus on a new comprehensive approach to assessing RBQM adoption; recent data on current levels of RBQM adoption among industry sponsors and CROs; recent data on expected future levels of use of RBQM components; perceived challenges associated with the implementation of RBQM components; and opportunities and benefits of RBQM implementation. We will discuss implications of these findings for the future of RBQM.

The dry-run study serves as a preparatory phase for high-risk projects. This non-interventional case study, enrolling 1% of the target population for the efficacy study, aimed to test processes such as eCOA and sample collection. A comprehensive Risk-Based Quality Management (RBQM) methodology was implemented, which included CP&D identification, risk identification, and management, reduced SDV/SDR, and centralized monitoring through QTLs, KRIs, and targeted review. This approach not only enhanced control over critical data collection but also facilitated swift identification and management of both predefined and newly emerging risks.

Historically, site monitoring was generally conservative in planning and execution, and significantly drove study cost. By shifting gears from One-Size-Fits-All towards End-to-End RBQM, we have enabled a comprehensive approach, leveraging cross-functional risk assessment; technology; and adaptive on-site, off-site and Centralized Monitoring activities to ensure data quality and subject safety. In our RBQM implementation journey, we have learned to be more focused and disciplined in our assessment of study-specific needs and our way of working to optimizing study and data validation monitoring.