Fueling a Quality-First Organization with Cultural Change and Risk-Based Quality Management (RBQM) Operational Improvements
Session details:
This session explores how integrating RBQM principles with a cultural shift can transform clinical trial quality and efficiency; it highlights the pivotal role of centralized monitoring in enabling real-time risk detection and proactive issue resolution. We will also explore the shift in the RBQM-era that affects the ways of working and innovating from analytics and AI to vendor oversight and management. Attendees will learn how adopting a risk-based mindset and leveraging advanced analytics fosters collaboration across teams, enhances data integrity, and drives continuous quality improvement in addition to considering how using quality by design as a broader business objective and partnering across R&D demonstrates the value of Quality to the organization.
Key takeaways include:
- Understanding the cultural transformation needed to embed a quality-first mindset across clinical operations
- Applying RBQM principles to identify and mitigate critical risks early in the trial lifecycle
- Utilizing centralized monitoring tools to detect data anomalies and site performance issues in real time
- Enhancing cross-functional collaboration to break down silos and improve communication on quality risks
- Leveraging adaptive quality management to continuously refine risk assessments and operational strategies
- Demonstrating regulatory compliance and improving trial outcomes through data-driven decision making and transparency
- Managing the operational complexity of acquisitions happening across the industry impacting the processes, people, technologies, and external stakeholders
- Discussing the change management approaches used to navigate the emotional engagement and upskilling needed to bring people to the next level
This interactive panel discussion equips clinical leaders with practical strategies to operationalize RBQM and cultural change for sustainable quality excellence.
