The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) renovation of Good Clinical Practice (GCP) represents a philosophical shift in the conduct of clinical research away from a one-size-fits-all approach to a more pro-active, risk-based approach. RBQM is the bedrock of drug development excellence: our goal is to enhance understanding and increase implementation of key topics detailed in ICH E6(R3). After soliciting direct feedback from our respective member companies, ACRO and TransCelerate have developed a set of tools to support the implementation of a strong foundation for quality in clinical development.

Risk Management and Centralised Monitoring, having been established for some time, should be at the core of management and oversight processes on clinical trials. This presentation will share the sponsor experience of preparing for an inspection, and the inspectors’ expectations in contrast to the reality of RBQM in application.

In today's complex clinical trial ecosystem, focusing on what matters is paramount for study success and patient safety. Historically, the industry’s approach to quality and compliance has been retrospective with audits and inspections. Recent changes within the regulatory landscape demonstrate a paradigm shift towards a more prospective approach. Integral to this is functional stakeholder engagement and execution of critical thinking to facilitate inclusion of quality and focus on what matters most, from clinical trial design through all trial milestones. Dedication of resources on what impacts study data quality and reliability and patient safety equally aligns with principles of risk proportionality.

This talk will address the challenge of managing vast amounts of information about past and ongoing clinical trials scattered across multiple source systems and documents, which often remain underutilised. It will delve into the implementation of the Details, Risk, Errors, and Mitigations (DREaM) browser, showcasing an integrated process for extracting, collating, and analysing data to derive meaningful insights and support informed risk management and decision-making.

At J&J, we are transforming clinical data review through AI-driven innovations that enhance automation, precision, and user experience. Our approach includes query optimization with BERT, smart autocomplete with RAG, duplicate detection, and natural language querying with FLAN-T5. These tools enable near real-time query optimization process, reducing delays and improving trial outcomes. This proactive, intelligent workflow bridges longstanding gaps, making data review more efficient and user-friendly, ultimately accelerating clinical decision-making and trial success.

Manual trackers may get a trial off the ground, but they won’t scale a program. In this session, we’ll walk through a real-world use case of moving from spreadsheet chaos to a streamlined, tech-enabled oversight model. Learn how one team replaced disconnected trackers with integrated tools—reducing manual effort, boosting data quality, and unlocking capacity to do more with less. We’ll explore what changed (and what didn’t), lessons learned, and how to make smart, right-sized upgrades even without a giant tech budget.

This presentation explores how reduced monitoring can enhance efficiency in early development clinical trials without compromising data integrity. By leveraging risk-based strategies and site partnerships, we can streamline oversight while maintaining regulatory compliance. Insights from feasibility planning and operational excellence will be shared, highlighting practical applications and future directions for optimising trial execution.

In this presentation, we’ll explore how advanced analytics serve as a crucial driver of improvements in clinical quality and inspection readiness. By providing quality signals, identifying potential risks, and enhancing decision-making processes, analytics significantly boosts operational efficiency. We’ll delve into the critical interplay between analytics and change management strategies, discussing best practices for successful implementation of analytics within the organization. With real-world examples, attendees will discover how leveraging analytics can foster a culture of continuous improvement and substantially elevate organisational performance. The pivotal role of analytics in enabling clinical quality and effective change management will be a central discussion theme.

During the session, the presenter will engage the audience in risk assessment of specific study designs. Participants will define critical-to-quality factors and key elements of their RBQM strategy. After that the real problems of the studies will be revealed. All cases will be based on real life stories.

RBQM—Is this a shared responsibility among study management functional areas? Or is it a standalone concept? At MSD, we are currently undergoing a change in the approach of implementing RBQM principles, and we are restructuring the organisation and revising processes. With this presentation, we’d like to share our journey, lessons learned, and where we’re heading.

At Novartis, implementing Risk-Based Quality Management (RBQM) has been more than a process, it’s been a strategic shift. By embedding our Process & Risk Surveillance (PRS) Team within the Business and building a strong partnership with Quality, we’ve enabled true cross-functional ownership of risk and integrated it directly into trial design and conduct, ensuring a strong feedback loop to global clinical trial processes. This session will share how we designed and operationalised our RBQM model, the key enablers for scaling it across the portfolio, and the lessons we've learned in making RBQM a core part of how we deliver clinical trials.