Speaker

Smaranda Doucet

Founder, FlowTrial

Pharm. Smaranda Doucet is a clinical research professional with nearly two decades of experience across CROs, sponsors, and investigator sites. She specializes in Sponsor Oversight and GCP compliance in global clinical trials, supporting sponsors in establishing robust oversight frameworks and strengthening quality governance across study teams. She is the founder of FlowTrial, a company focused on advancing modern sponsor oversight practices.

Speaker's program

Day 1

12:00

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12:30

The CRA Mindset Shift: From Monitoring Details to Recognizing Patterns Across the Study

The updated ICH E6(R3) guideline is not asking CRAs to complete more tasks — it is asking them to think differently. In today’s monitoring reality, where documentation, platforms, and operational pressure continue to increase, important signals can easily become lost in detail. This session explores the mindset shift from focusing on isolated findings to adopting an oversight perspective — recognizing patterns, understanding interconnections, and seeing the broader impact across the study. By moving from monitoring details to oversight thinking, CRAs can strengthen risk recognition, avoid unnecessary escalation, and focus their attention where it truly matters for patient safety and data integrity.

Day 1

14:30

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15:00

Tech vs Human Insight: Can They Coexist in Monitoring?

As technology plays an increasingly central role in clinical monitoring, CRAs are asked to balance digital tools with human judgment and experience. In this panel discussion, technology leaders and former CRAs explore where tools truly add value, where human insight remains irreplaceable, and how CRAs can use technology without losing oversight, context, and critical thinking.

May 12‒13, Barcelona, Spain

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