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Clinical Trial Oversight Services

Guarantee protocol compliance and trial success with independent, expert oversight

Compliant with FDA 21 CFR Part 312 Subpart D requirements

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Our Approach To Clinical Trial Oversight

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Study Startup

  • Pre-study site visits

  • Protocol review and risk assessment

  • Site initiation oversight

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Study Maintenance

  • Interim monitoring visits

  • Real-time compliance monitoring

  • Risk mitigation and resolution

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Study Close-Out

  • Close-out visit oversight

  • Data integrity verification

  • Regulatory compliance confirmation

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Why Choose Independent Oversight?

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Unbiased Monitoring

Independent oversight ensures objective assessment of CRO performance and trial progress

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Enhanced Risk Management

Early identification, engagement and resolution of critical compliance issues

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Trial Protection

Additional layer of expertise to prevent trial delays and failures

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Regulatory Expertise

Deep understanding of FDA requirements and ICH/GCP guidelines

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Real-Time Insights

Immediate feedback and recommendations during site visits

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Quality Assurance

Rigorous monitoring of data integrity and protocol adherence

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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.

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100% Protocol Compliance

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Zero Regulatory Findings

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3 Months Time Saved

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Ready to Ensure Your Trial's Success?

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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