Independent Oversight that Strengthens Your Trials

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R3 Ready Check
Technical expertise.
Zero conflict of interest.
Full regulatory alignment.
The QARP delivers independent clinical oversight and monitoring services tailored to sponsors, CROs, and quality teams operating under global GCP frameworks.
We work alongside your clinical teams to reinforce compliance, elevate quality, and support regulatory confidence—without duplicating CRO roles or creating operational noise.
What You Gain Working with The QARP:
  • Regulatory Confidence
    Comprehensive preparation for inspections, complete with validated documentation and structured readiness tools.
  • Improved Operational Quality
    Clear accountability across CRO and site activities. Reduced protocol deviations and better data fidelity.
  • Objective Expert Review
    GCP auditors, MDs, and QA experts bringing global experience to your trial oversight—without internal bias.

Why Independent Oversight Matters

Clinical trials are complex systems with multiple stakeholders. When quality oversight is embedded within CROs or project teams, conflicts of interest can obscure critical risks. The QARP operates outside this structure—delivering focused, independent evaluations that help you:
  • Identify systemic quality risks before they escalate
  • Meet ICH GCP E6(R3) oversight expectations, including section 3.9
  • Demonstrate audit readiness with documented, traceable actions
  • Improve performance at site, vendor, and CRO levels
Contact Our Team Let’s Discuss Your Trial
Our Oversight Model Covers Three Critical Domains:
  • 1. On-Site Clinical Oversight and Co-Monitoring

    • CRA performance reviews — protocol adherence, data quality, SDV
    • Site-level risk detection — supported by root cause analysis and actionable CAPAs
    • Real-time feedback — insights delivered directly to study leads and QA

    Output: Structured field visit reports, issue logs, and documented follow-up.
  • 2. Vendor, Site, and CRO Auditing

    • Independent audits in alignment with E6(R3), FDA, EMA, and MHRA expectations
    • Risk-based assessments of outsourced trial functions and CRO operations
    • Inspection readiness support — including tailored checklists, gap analyses, and mock audits

    Output: Formal audit reports, findings mapped to risk categories, CAPA oversight frameworks.
  • 3. Centralized Reporting & Strategic Follow-Up

    • KPI-based dashboards — track quality metrics, protocol compliance, and CAPA status
    • Oversight summaries — final reports formatted for TMFs and inspection packages
    • Decision support — executive summaries for QA leads and governance boards

Built for Clinical Teams That Need Clarity, Not Noise
We do not replace your internal teams or CRO. We provide focused, evidence-based oversight that complements your operations and supports sponsor-level responsibilities. Every engagement is tailored to your trial’s risk profile, operational model, and timelines.
Let’s Talk About Your Oversight Needs
Contact Us
Phone number: +34 625263964
Email: info@theqarp.com