In this resource
Strengthen your processes and increase data-driven decision-making for faster study start-ups.
Strengthen your processes and increase data-driven decision-making for faster study start-ups.
Introduction
The revised ICH E6(R3) Good Clinical Practice guideline marks one of the most significant shifts in clinical trial oversight in years. Sponsors are now expected to demonstrate continuous, risk-based and traceable oversight across outsourced clinical activities. Clinical Maestro refers to this operating model as Continuous Vendor Governance™.
What Changed with ICH E6(R3)?
Organizations must move from periodic reviews to continuous oversight supported by connected operational data, documented governance decisions and inspection-ready evidence.
Traditional Vendor Management vs Continuous Vendor Governance™
Traditional: periodic reviews, spreadsheets, static KPI reports, reactive escalations.
Continuous: continuous monitoring, connected governance, KPI trends, AI insights, early risk detection and complete audit trail.
Why Vendor Oversight Is Becoming More Complex
Sponsors manage CROs, laboratories, imaging providers, technology vendors and subcontractors while governance information remains fragmented across systems.
The Five Pillars of Continuous Vendor Governance™
- Vendor Qualification
- Performance & KPI Management
- Risk & Compliance Oversight
- Contract & Change Order Governance
- AI-Powered Governance Intelligence
Inspection Readiness
Inspection readiness should be a continuous capability supported by traceable governance records, KPIs, risk assessments and AI-generated insights.
Implementation Roadmap
- Centralize vendor data
- KPI monitoring
- Governance workflows
- Continuous risk monitoring
- AI Governance Intelligence
Frequently Asked Questions
What is continuous vendor oversight?
Why is ICH E6(R3) important?
How does AI improve vendor oversight?
How is Continuous Vendor Governance™ different from vendor management?
What are the biggest sponsor challenges?
Key Takeaways
ICH E6(R3) requires continuous oversight. Continuous Vendor Governance™ operationalizes these expectations through connected governance, AI and inspection-ready processes.
Related Resources
Vision Product Page
E6(R3) Webinar
AI Insight Reports
CRO Change Orders Webinar
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In this resource
Strengthen your processes and increase data-driven decision-making for faster study start-ups.
Enjoying this release?
RESOURCES
Explore Expert Insights and Resources for Clinical Excellence
Webinars
Oversight is no longer periodic or document-driven. It must be continuous, risk-based, and fully traceable across vendors, studies, and services.
Read more
Blogs
From Vendor Management to Real-Time Control in Clinical Trials
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Case Studies
Faced with inefficiencies, compliance risks, and fragmented communication, a biopharma company dramatically enhanced its vendor governance by implementing VISION!
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DEMO
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