Did You Know?
ICH E6(R2) regulations dictate sponsors must ensure oversight of any trial-related duties and functions,
even when trials are outsourced to CROs.
Failure to comply with regulatory responsibilities can result in critical findings, slowing trials and increasing costs.
Is your organization compliant with ICH E6(R2)?
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Inadequate review documentation when monitoring visit reports (MVRs) were created by CROs
Lack of review for protocol deviations
No evidence to demonstrate compliance with oversight activities and how the trial was conducted
Less Risk, More Confidence in Outsourced Trials
Effectively demonstrating study oversight ensures compliance with global regulations and gives you confidence in the integrity of your trials. A modern CTMS provides real-time visibility and oversight, reducing compliance risk and elevating confidence that trials are high-quality and run to the highest standards.
Study Oversight in Veeva Vault CTMS
Less Findings, Fewer Delays
Avoid study delays and reduce findings by providing auditable data and documentation. Comprehensive monitoring capabilities and communication logs in Vault CTMS make it easy to provide evidence of oversight to regulators throughout the course of a trial. Watch Regulatory Compliance Vlog
Faster Trials, Higher Quality
Capture, track, and manage protocol deviations, issues, and follow-up items across sites and studies. Reduce bottlenecks and enable effective full lifecycle issue management, from identification through to resolution. Watch Issue Management Vlog
Real-Time Insights,
Actionable at Scale
Get clear visibility to global study performance with real-time reports and dashboards. Drill down to study data to take immediate action and increase efficiency.
Watch Reports and Dashboards Vlog
Stronger CRO Engagement,
More Collaboration
Actively monitor study and CRO performance with line of sight to key milestones and metrics - outstanding queries by study, MVR quality findings, protocol deviations by site, time to issue resolution, enrollment over time, and more. Measure CRO adherence to OLAs and SLAs to strengthen contract negotiations and ultimately drive better trial outcomes.
Watch CRO Monitoring Vlog
Keep Outsourced Studies on
Track and Compliant with Vault CTMS
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