At Premier, we move beyond traditional fixed onsite monitoring to deliver a flexible, risk-based monitoring strategy that integrates onsite, remote, and centralized methods. Our adaptive model uses technology and data-driven insights to focus on critical quality factors, patient safety, and site performance—delivering superior oversight without unnecessary burden.

Adaptive Monitoring That Works

Our approach includes using an optimal mix of:

• Centralized data monitoring leveraging targeted analytics to identify protocol deviations, trends, gaps, or risks
• Onsite or remote source data review/source data verification (SDR/SDV) using a subject visit sampling approach

We focus on complete, logical, and timely data reporting, with special attention to critical to quality and high-risk areas like patient safety, endpoint accuracy, and protocol compliance.

Integrated Quality Risk Management (IQRM)

Premier builds a fit-for-purpose monitoring strategy for each study based on a thorough risk assessment. Our Central Monitors, Data Managers, and Medical Monitors collaborate to pinpoint vulnerabilities in data and/or processes and proactively mitigates them—strengthening data integrity.

Using our Remarque platform, we provide near real-time review of site data to:

• Rapidly identify protocol deviations and issues
• Deliver actionable insights that improve outcomes
• Guide CRA focus and optimized risk-based monitoring (RBM) strategy

Monitoring Powered by Central Monitor

Every study is assigned a dedicated Central Monitor responsible for real-time oversight of:

• Protocol compliance
• Site data entry rates and query resolution performance
• Emerging risk signals on efficacy and safety data

Data from EDC, lab systems, IVRS/IWRS, and other sources are aggregated, analyzed, and monitored at patient, site, and study levels using both foundational and custom data visualizations and key risk indications. Central Monitor reviews include:

• Assessments for missing/invalid data
• Checks for data inconsistencies
• Identification of protocol deviations
• Compliance with adverse event reporting
• Cross-validation (e.g., lab vs. EDC discrepancies)

Each insight results in risk-aligned actions—from follow-up calls to escalated site visits—ensuring proactive resolution of issues before they impact study quality.

Strategic RBM and Site Management Components:

• Custom SDR/SDV Sampling based on risk to patient safety and data integrity
• Interim Monitoring Visits (IMVs) to reinforce early protocol adherence
• Site Management Calls (SMCs) to address trends, compliance, and key issues
• Routine Site Contacts (RSCs) to follow up, support enrollment, and resolve findings

Key Elements of Our Monitoring Strategy

• Identification of Critical Data Points. Beyond primary/secondary endpoints, we identify study-specific critical data that guide both centralized and onsite monitoring focus.
• Safety-Driven Monitoring Triggers. Subject safety signals or site-specific issues trigger immediate monitoring intervention to ensure patient welfare and regulatory compliance.
• Site Process Oversight. Monitoring is focused on ICH GCP requirements and protocol compliance specific to the data and process critical to maintaining data quality and patient safety.
• Site Responsiveness. Sites are managed via performance dashboard including data entry and query turnaround time.
• Clear Documentation. We ensure monitoring requirements are explicitly detailed in the Clinical Monitoring Plan—no ambiguity, just actionable clarity.
• Dynamic Site Performance Evaluation. We continuously assess site performance—adjusting monitoring frequency based on real-world performance trends, staff turnover, or protocol deviations.

Why Choose Premier?

• Risk-Focused Monitoring aligned with global regulatory expectations
• 20% faster issue detection than traditional models
• Lower site burden with 60% of monitoring activities conducted via central monitoring
• Clear cross-functional responsibilities that improve team efficiency
• Superior quality and compliance across all trial phases
• Patient-centered focus protecting rights, safety, and data integrity

Let’s transform your clinical trial oversight together. Contact Premier today to discuss an efficient, scalable approach, built for your success.