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. Join this timely webinar.
USDM introduces CRO Assurance, a modular, managed service designed to help life sciences companies meet these new obligations with confidence. We’ll explore how this service 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.
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
Watch to discover how CRO Assurance helps you stay compliant, reduce risk, and future-proof your oversight practices in a new era of clinical regulation.