The release of ICH E6(R3) has redefined sponsor responsibilities in clinical research, placing unprecedented emphasis on ongoing oversight of outsourced systems and services. This pivotal regulatory shift mandates that sponsors not only conduct periodic audits but also establish continuous IT governance of their CROs’ systems—an expectation many organizations are still grappling to operationalize.
In this on-demand webinar, USDM introduces CRO Assurance, a modular, managed service designed to help life sciences companies meet these new obligations with confidence.
What you’ll learn
- How to align with ICH E6(R3)’s heightened requirements for CRO oversight and data integrity.
- How to implement regular IT governance meetings and executive debriefs with your CROs.
- How to review change logs and database audit trails bi-annually, and maintain an up-to-date inventory and annual review of CRO IT-related SOPs.
- How to enable real-time monitoring of cybersecurity risks through continuous assessments and integrated third-party risk management tools.
- How a scalable service model brings multiple CROs and their systems into scope—illustrated with a real-world example—while reducing IT and quality overhead.
Meeting the New Standard for CRO Oversight
USDM’s CRO Assurance enables sponsors to:
- Align with ICH E6(R3)’s heightened requirements for CRO oversight and data integrity
- Implement regular IT governance meetings and executive debriefs with CROs
- Review change logs and database audit trails bi-annually
- Maintain an up-to-date inventory and annual review of CRO IT-related SOPs
- Enable real-time monitoring of cybersecurity risks through continuous assessments and integrated third-party risk management tools
We also share a real-world example of how two CROs and their systems were brought into scope, demonstrating how a scalable service model can protect your organization from regulatory risk while streamlining compliance and reducing IT and quality overhead.
Why this matters: ICH E6(R3) moves sponsor oversight from a point-in-time audit exercise to an ongoing discipline. Continuous IT governance, audit-trail review, and life sciences cybersecurity monitoring are now part of staying compliant—not a once-a-year checkbox. USDM’s view is that this oversight should be operationalized as a repeatable, managed service so quality and IT teams can scale across multiple CROs without absorbing unsustainable overhead.
Who Should Watch
Clinical Operations, Quality, IT, and Regulatory Affairs leaders in life sciences companies, particularly those sponsoring studies through external CROs.
Speakers
- Hovsep Kirikian, VP of Strategy & Operations, USDM
- Brian Rankin, Head of Cybersecurity, USDM
FAQ: ICH E6(R3) and CRO IT Governance
What changed for sponsors under ICH E6(R3)?
ICH E6(R3) redefines sponsor responsibilities by placing unprecedented emphasis on ongoing oversight of outsourced systems and services. Sponsors are now expected to go beyond periodic audits and establish continuous IT governance of their CROs’ systems.
What is USDM CRO Assurance?
CRO Assurance is a modular, managed service from USDM designed to help life sciences companies meet ICH E6(R3)’s new obligations with confidence—covering CRO oversight, data integrity, IT governance meetings, audit-trail and change-log reviews, SOP inventory, and cybersecurity monitoring.
How does CRO Assurance support ongoing oversight rather than one-time audits?
The service enables regular IT governance meetings and executive debriefs with CROs, bi-annual review of change logs and database audit trails, an up-to-date inventory and annual review of CRO IT-related SOPs, and real-time monitoring of cybersecurity risks through continuous assessments and integrated third-party risk management tools.
Can this approach scale across multiple CROs?
Yes. The webinar shares a real-world example of how two CROs and their systems were brought into scope, demonstrating how a scalable service model can protect your organization from regulatory risk while streamlining compliance and reducing IT and quality overhead.
Who should watch this webinar?
It is intended for Clinical Operations, Quality, IT, and Regulatory Affairs leaders in life sciences companies, particularly those sponsoring studies through external CROs.
Watch on-demand: See how CRO Assurance helps you stay compliant, reduce risk, and future-proof your oversight practices in a new era of clinical regulation. Have questions about applying ICH E6(R3) oversight to your CROs? Contact USDM to talk through your continuous compliance approach.