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In this sponsored episode, originally produced as part of CRScube’s Clinical Data Talks podcast, we’re pleased to share a compelling conversation hosted by Sylvain Berthelot, VP of Strategy and Marketing at CRScube. Sylvian welcomes Brian Barnes, Director of Risk Management Strategy at BioNTech, to explore the human and strategic dimensions of risk-based quality management (RBQM). Drawing from his rich experience across CROs, technology vendors, and now a sponsor organisation, Brian shares how his role as a “risk assessment facilitator” reflects a broader cultural shift: developing a company-wide risk-focused mindset and moving risk management upstream into study design and operational planning. Sylvain and Brian talk about building risk frameworks from the ground up, demonstrating return on investment for RBQM and confronting resistance and misconceptions. Brian offers practical insight into why RBQM is less about the tools and more about people, collaboration, and culture. Tune in to discover what “good” risk management looks like and how to make it stick –across teams, trials, and organisations. To learn more visit: https://www.crscube.io/