What does good risk management actually look like in clinical trials—and why are so many organizations still getting it wrong?

In this episode of Risk Revolution, the team explores how the latest update to ICH E6(R3) is reshaping clinical trial design and execution, with a deeper focus on risk-based thinking, patient-centricity, and quality-by-design.

Joined by clinical quality expert Joy Whitsett, the discussion moves beyond theory to examine how risk management is really being applied—and where gaps still exist.

They cover:

• Why risk management in clinical trials is often performed, but not truly integrated
• The shift toward quality by design at the protocol level
• How sponsors and CROs misalign on risk ownership and priorities
• Why many risk assessments fail to focus on what actually matters: patient safety and meaningful data
• The role of ICH E6(R3) in driving a more structured, risk-based approach
• How patient experience and feasibility should shape trial design
• Why over-reliance on templates, tools, and “check-the-box” processes can dilute real risk thinking
• Practical ways to implement risk-based decision-making without adding complexity

The key takeaway: effective risk management isn’t about doing more—it’s about focusing on what matters most, earlier in the process, and aligning teams around real-world outcomes.

For professionals working across clinical, quality, and regulatory functions, this episode offers a clear look at how risk thinking is evolving—and what it takes to apply it in practice

Link to ICH E8 R1
Link to ICH E6R3
PDA Southeast Chapter QRM Practical Workshop Registration Link

Is the new ICH Q9 training just more guidance—or a reset for how risk should be managed?

In this episode, we break down the latest training materials and what they signal for Quality Risk Management (QRM) in practice.

We cover:

• Why this release feels like a shift in expectations—not just an update
• The gap between risk tools and real decision-making
• Challenges applying dense guidance in real-world settings
• What organizations may need to rethink in existing QRM programs

If your team is focused on completing risk assessments rather than improving decisions, this episode will challenge your approach.