ICH E6(R3) Sponsor Oversight

ICH E6(R3) Sponsor Oversight: What Clinical Compliance Teams Must Know

With ICH E6(R3) taking effect this July, clinical research sponsors face a new mandate: move beyond passive documentation and adopt a more proactive, risk-based approach to oversight. The latest guidance signals a shift—sponsor oversight must be continuous, data-driven, and directly linked to risk management and governance processes.

This transformation may feel daunting, but the path forward doesn’t have to be unclear.

Join the Webinar: Translating ICH E6(R3) Into Practice

On April 29 at 11AM ET / 8AM PT, join industry experts for a practical, real-world discussion:

Translating R3 Data Governance & Oversight into Practice

This session is designed for clinical compliance professionals, QA leaders, and operations teams seeking to understand how to apply ICH E6(R3) principles in a real-world context.

What You’ll Learn

🔍 Making Data Governance Actionable

ICH E6(R3) emphasizes the importance of data governance—but sponsors must go beyond policy documents. We’ll explore how to create review and response processes that make governance operational, not just theoretical.

🛡 Embedding Risk Management from the Start

The updated guidance requires risk management to be proactive and sponsor-driven. Learn how to build frameworks early that support effective sponsor oversight throughout the study.

📊 Leveraging Data Visibility to Improve Oversight

With real-time access to operational and quality data, sponsors can detect protocol deviations faster and fulfill their oversight responsibilities more effectively. Visibility isn’t optional—it’s critical.

Expert Speakers

🎙 Donna Dorozinsky, CEO, Just in Time GCP
🎙 Bryce Lugar, Director of Product, TruTechnologies
🎙 Collier Wright, VP of Solutions, TruTechnologies

Together, they’ll walk through what ICH E6(R3) sponsor oversight looks like in practice—from both a compliance and technology perspective.

Why This Webinar Matters

This isn’t just a regulatory update—it’s a call to action for sponsors to strengthen their clinical compliance systems. You’ll walk away with insights you can apply immediately to prepare your team and systems for the R3 transition.

📅 April 29 | 11AM ET / 8AM PT
🔗 Register Here 


Get ahead of the curve. Learn how to implement ICH E6(R3) sponsor oversight in a way that’s practical, scalable, and inspection-ready.

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