Clinical Trial Oversight Services

Guarantee protocol compliance and trial success with independent, expert oversight
Compliant with FDA 21 CFR Part 312 Subpart D requirements

Our Approach To Clinical Trial Oversight

Study Startup

Pre-study site visits
Protocol review and risk assessment
Site initiation oversight

Study Maintenance

Interim monitoring visits
Real-time compliance monitoring
Risk mitigation and resolution

Study Close-Out

Close-out visit oversight
Data integrity verification
Regulatory compliance confirmation

Why Choose Independent Oversight?

Unbiased Monitoring

Independent oversight ensures objective assessment of CRO performance and trial progress

Enhanced Risk Management

Early identification, engagement and resolution of critical compliance issues

Trial Protection

Additional layer of expertise to prevent trial delays and failures

Regulatory Expertise

Deep understanding of FDA requirements and ICH/GCP guidelines

Real-Time Insights

Immediate feedback and recommendations during site visits

Quality Assurance

Rigorous monitoring of data integrity and protocol adherence

Success Story: Multi-Site Phase III Trial

Our hands-on oversight approach helped identify and prevent potential compliance issues across all trial sites, ensuring data integrity and regulatory compliance throughout the study.

100% Protocol Compliance

Zero Regulatory Findings

3 Months Time Saved

Ready to Ensure Your Trial's Success?

Let's discuss how our experienced team can provide the oversight needed to protect your trial's integrity and ensure regulatory compliance.

Schedule A Consultation