Independent Monitoring. Assured Performance

AQ360 provides specialized third-party monitoring services for clinical trials of all phases, delivering transparent oversight and enhanced operational control. Our expert monitors ensure strict protocol adherence, robust data quality, and patient safety, while proactively identifying potential risks and resolving issues before they impact study timelines. Sponsors benefit from actionable insights, consistent site performance, and reliable progress tracking, enabling confident decision-making and successful trial outcomes.

AQ360 – Third-Party Monitoring Services

With over 10 years of hands-on experience in clinical trial monitoring, AQ360 provides independent, expert oversight to ensure trial integrity, protocol compliance, and participant safety across all study phases. Our team has successfully monitored 100+ trials across diverse therapeutic areas, giving sponsors and CROs transparent, real-time insights and actionable recommendations that enhance site performance and operational efficiency. Our monitoring approach emphasizes proactive issue detection, risk-based oversight, and comprehensive data verification, helping trials stay on schedule, maintain high-quality standards, and meet regulatory expectations. By leveraging experienced monitors, structured reporting, and technology-enabled tools, AQ360 transforms monitoring into a strategic advantage, enabling faster decision-making, reliable data, and audit-ready documentation.

Key Services:

Risk-Based Site Monitoring

Focus monitoring efforts on high-risk sites and critical data points to ensure efficient oversight and early risk mitigation.

On-Site and Remote Monitoring Visits

Conduct both physical and virtual visits to verify source data, evaluate protocol compliance, and ensure patient safety.

Source Data Verification & CRF Reconciliation

Compare clinical records with case report forms to maintain high-quality, accurate, and reliable trial data.

Protocol Adherence Oversight

Monitor adherence to study protocols to minimize deviations, ensure standardization, and maintain trial validity.

Patient Safety & Adverse Event Monitoring

Identify, report, and track adverse events or safety concerns across multiple sites, ensuring timely intervention.

Investigator Training & Guidance

Provide continuous training, clarification, and support to site staff to maintain operational and regulatory compliance.

Centralized Reporting & Dashboard Updates

Offer real-time access to site performance, enrollment metrics, and monitoring outcomes through technology-enabled dashboards.

CAPA Tracking & Issue Resolution

Ensure prompt follow-up and resolution of identified issues through structured CAPA processes.

Multi-Site Performance Tracking

Evaluate performance across all trial locations, identifying trends, deviations, and best practices for operational consistency.

Regulatory Compliance Support

Assist in maintaining inspection-ready records and adherence to global and local regulatory requirements.

Solution:

Risk-Based Monitoring – Focus on high-risk sites and critical data points to optimize monitoring efficiency and mitigate study risks.

Structured Site Oversight – Routine on-site visits, remote monitoring, and technology-enabled tracking ensure continuous compliance and performance.

Proactive Issue Identification & CAPA – Early detection and resolution of deviations, operational gaps, or safety concerns prevent escalation.

Standardized Workflows – Consistent monitoring practices reduce errors, improve efficiency, and ensure data integrity across all sites.

Real-Time Reporting & Dashboards – Sponsors receive transparent insights into enrollment, site progress, compliance, and data quality.

Regulatory Compliance Support – Continuous review of essential documents and trial procedures keeps sites inspection-ready.

Investigator Training & Guidance – Ongoing support and training enhance staff competency, protocol adherence, and site collaboration.

Comprehensive Data Verification – Source data review and CRF reconciliation ensure high-quality, audit-ready trial data.

Optimized Resource Allocation – Efficient assignment of monitors and use of digital tools reduce operational costs and workload.

Continuous Risk Mitigation – Proactive monitoring strategies prevent issues from affecting trial outcomes.

Benefits of AQ360 Monitoring Services:

Enhanced Protocol Adherence – Minimized deviations across all sites, ensuring high-quality trial execution.

Improved Data Quality & Integrity – Accurate, complete, and reliable trial data suitable for regulatory submission.

Early Issue Detection & Resolution – Prompt corrective actions reduce risks and prevent delays.

Consistent Multi-Site Performance – Standardized monitoring ensures uniform operational quality across locations.

Regulatory Compliance & Audit Readiness – Continuous oversight keeps sites inspection-ready and compliant.

Operational Efficiency & Cost Savings – Streamlined processes, remote monitoring, and structured workflows reduce effort and expenses.

Patient Safety Assurance – Adverse events, protocol deviations, and other safety concerns are identified and addressed promptly.

Transparent Reporting & Sponsor Visibility – Detailed, real-time reports provide actionable insights for informed decision-making.

Investigator Engagement & Support – Continuous guidance, training, and collaboration improve staff competency and protocol adherence.

Actionable Insights for Continuous Improvement – Objective recommendations help sponsors optimize site performance and overall trial quality.