actON QbD | Episode 2: Thinking critically to identify risks

Identifying risks that truly matter is one of the most critical steps in adopting a successful risk-based approach to clinical trials. But with a constant stream of data, evolving protocols, and growing compliance demands how can clinical teams separate real risks from background noise?

In this episode of actON QbD, we dive into the process of thinking critically to uncover meaningful risks before they impact patient safety, data quality, or study timelines.

What You’ll Learn:

• What does “critical” mean in risk identification?
  Discover how to evaluate risks based on potential impact, detectability, and likelihood.

• Common pitfalls in risk identification
  Learn how misjudging or overlooking risks can derail your trial and how to avoid it.

• Best practices for evaluating and prioritizing risks
  Use structured thinking to spot early warning signs and avoid trial deviations.

• From awareness to action
  Explore how Cyntegrity’s MyRBQM® Portal helps you document, monitor, and respond to risks in a timely, traceable way.

Who Should Join:

• Clinical Quality Leads

• Study Risk Managers

• CRAs and Clinical Project Managers

• Regulatory and Compliance Teams

• Anyone working on QbD, QMS, or RBQM initiatives

Why It Matters:

Identifying risks is not enough. What separates high-performing clinical teams is what they do next how they respond, escalate, document, and resolve issues before they compromise the study. That begins with thinking critically about the risks you choose to act on.

Don’t Miss This Episode!

Join us to sharpen your skills in risk recognition and assessment. Whether you’re just starting your RBQM journey or refining an existing approach, this session will give you the mindset and tools to make your risk strategy work.