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mindsON RBQM | Episode 34: Change – Why 70% fail and how to succeed in Risk Management

Despite wide acknowledgment of the importance of Risk Management in clinical trials, implementation gaps persist. The draft ICH E6 (R3) guidelines place a strong emphasis on embedding risk-based thinking across all aspects of a trial from oversight to monitoring and data integrity. And yet, while 90% of organizations perform risk assessments, only 50% use Key Risk Indicators (KRIs) and just 25% implement Quality Tolerance Limits (QTLs) despite QTLs being a requirement since 2016.

So why are these essential elements still missing from many processes?

The truth is, change is hard. Studies show that up to 70% of change initiatives fail, often due to resistance, unclear communication, or cultural misalignment. But failure isn’t inevitable.

In This Episode:

Join our expert speakers, Keith Dorricott and Raik Knieknecht, as they share hard-won insights and field-tested strategies to help your organization not only comply with ICH E6 (R3) but thrive under it. This episode is highly interactive and grounded in real-world experience.

What You’ll Learn:

  • Why change initiatives fail and how to avoid the same pitfalls in your RBQM rollout

  • Common barriers in implementing KRIs, QTLs, and centralized monitoring

  • How to engage teams, clarify roles, and foster a culture of shared responsibility

  • Practical tools and frameworks to make Risk Management stick across your operations

  • Real-life stories of success (and failure) in adopting ICH E6 (R3)

Who Should Attend?

This session is ideal for:

  • Clinical Operations Leaders

  • Risk Managers

  • QA Professionals

  • Project Managers

  • Regulatory Affairs

  • Anyone involved in driving change and ensuring compliance with ICH E6 (R3)

Key Takeaways:

  • Understand the new Risk Management expectations of ICH E6 (R3)

  • Learn how to manage resistance to change and boost engagement

  • Get actionable frameworks to lead sustainable, cross-functional transformation

Don’t Miss This!

With Keith and Raik’s guidance, you’ll walk away with a deeper understanding of how to lead change, embed risk-based quality principles, and create lasting impact in your clinical trial operations.

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