Clinical Trial Monitoring

Precision Monitoring for a Dynamic Clinical Landscape

The iGlobal Clinical Trial Monitoring approach is designed to adapt seamlessly to the evolving needs of your trial. By integrating disciplined processes with flexibility and innovation, we identify, mitigate, and monitor risks to ensure subject safety, data integrity, and trial success.

Our holistic, adaptive monitoring process is evaluated continuously throughout the trial lifecycle, directing oversight activities to areas of greatest risk. This targeted focus enables efficient resource allocation and ensures the highest standards of quality and compliance at every phase of your study.

Adaptive Monitoring with iGlobal

1. Protocol Evaluation
The process begins with an in-depth protocol evaluation conducted by our multidisciplinary team. This evaluation identifies critical study components, potential risks, and tailored mitigation strategies to optimize safety and quality outcomes.

2. Centralized Monitoring
Using advanced data analytics, centralized monitoring provides early detection of quality, safety, and operational risks. This includes:

Continuous data review to identify trends and anomalies.
Proactive remote monitoring visits to address risks before they escalate.

3. On-Site Visits
When in-person oversight is necessary, our expert monitors conduct on-site visits to:

Review source documents and address data that cannot be validated remotely.
Provide site support, education, and re-education based on findings from centralized reviews.

Why Choose iGlobal for Clinical Trial Monitoring?

Risk-Focused Precision: Our adaptive process identifies the most critical study risks, ensuring resources are allocated where they have the greatest impact.
Integrated Expertise: Our clinical monitors collaborate with Medical Monitors, Data Review Specialists, and Therapeutic Experts to provide scientific insights and practical solutions for a comprehensive monitoring strategy.
Seamless Technology Integration: Leveraging advanced tools like centralized data dashboards and real-time analytics, we ensure proactive and data-driven monitoring.
Dynamic Flexibility: Whether your study requires remote, centralized, or on-site monitoring, we tailor our approach to meet your trial’s specific needs.

Protecting Data Integrity and Subject Safety
At iGlobal, our Clinical Trial Monitoring teams are more than just observers—they’re strategic
partners in ensuring your trial stays on track. With expertise in risk mitigation, operational
efficiency, and site engagement, we provide a robust, proactive approach that keeps your study
moving forward without compromising quality or safety.

Choose iGlobal Clinical Research for adaptive, precision monitoring solutions that deliver results.

The iGlobal Advantage in Clinical Trial Monitoring

Adaptive Monitoring Powered by Precision and Collaboration

iGlobal Clinical Trial Monitoring services are built on a dynamic Risk-Based Monitoring (RBM) Framework designed to ensure subject safety, data integrity, and trial success. By combining advanced technology, cross-functional expertise, and customized site and subject engagement strategies, we deliver monitoring solutions tailored to the unique needs of your study.

Our RBM Framework

Our RBM framework includes four adaptive stages, enhanced by continuous assessment and refinement throughout your trial:

1. Protocol Evaluation:

Comprehensive protocol review: Identifies critical study elements, risks, and mitigation strategies.
Customized combinations of monitoring: Centralized, on-site, and remote monitoring ensure optimized resource allocation.

2. Establish Controls:

Standard Operating Procedures (SOPs): Customized through iGlobal Project Documentation to address study-specific risks.
Project Plans and tailored training: Ensure operational alignment and consistency across teams and sites.

3. Centralized Monitoring:

Real-time data reviews: Provide oversight for medical surveillance and operational performance.
Early identification of risks: Data-driven insights help identify quality, safety, and operational risks.

4. Risk Remediation:

Immediate action plans: Address identified risks, including site education, additional monitoring activities, and protocol adjustments.
Proactive measures: Ensure compliance, mitigate challenges, and maintain study momentum.

iData Insights™: Real-Time Analytics and Custom Dashboards

At iGlobal, we harness the power of our proprietary iData Insights™ platform, an interactive analytics tool that transforms vast datasets into actionable insights. By integrating data from diverse sources—central labs, EDC, IRT, eConsent, eDiaries, and decentralized trial tools—our platform enables real-time trend analysis and risk mitigation.

Key Features:

Customized Dashboards: Study-specific visualizations tailored to project risks.
Granular Reporting: Subject, site, country, and program-level reports provide deep insights for decision-making.
Proactive Risk Management: Anomaly detection and issue escalation ensure swift and effective responses.
CRA Optimization: Remote monitoring capabilities reduce the need for frequent site visits, allowing CRAs to focus on quality and site engagement.

Empowered Oversight: Study teams and sponsors have on-demand access to data and insights, enabling transparency and forward-looking decisions.

Risks can arise at any stage of a trial. Our cross-functional teams collaborate to monitor and address risks throughout the study lifecycle:

Medical Monitors and Data Clinicians: Provide continuous oversight of subject data and safety, supported by therapeutic expertise.
Safety Teams and Advanced Practitioners: Work in tandem with site staff to ensure protocol compliance and subject well-being.
Integrated Study Leadership: A cohesive partnership between the Medical Monitor and Clinical Trial Manager ensures balanced focus on clinical and operational data.

At iGlobal, we recognize that one-size-fits-all strategies don’t work. Our tailored monitoring solutions align with site capabilities, ensuring efficient execution and reduced burden:

Site Partnerships: With a network of trusted investigators and research sites, we customize monitoring strategies to align with each site’s unique processes, minimizing site burden and fostering strong relationships.
Subject-Centric Design: Decentralized services and tailored engagement tools ensure participant convenience and enhance protocol compliance. By minimizing subject burden, we boost retention and satisfaction while maintaining data quality.

Empowering CRAs with World-Class Training

iGlobal Academy: Excellence in CRA Training and Development

At iGlobal, we recognize that one-size-fits-all strategies don’t work. Our tailored monitoring solutions align with site capabilities, ensuring efficient execution and reduced burden:

Site Partnerships: With a network of trusted investigators and research sites, we customize monitoring strategies to align with each site's unique processes, minimizing site burden and fostering strong relationships.
Subject-Centric Design: Decentralized services and tailored engagement tools ensure participant convenience and enhance protocol compliance. By minimizing subject burden, we boost retention and satisfaction while maintaining data quality.

The iGlobal Difference

With decades of experience, advanced technology, and a client-focused philosophy, iGlobal Clinical Monitoring ensures every aspect of your study is managed with precision and care.

Partner with us for adaptive, collaborative, and technology-driven monitoring solutions that drive success at every stage.

Choose iGlobal: Precision Monitoring. Trusted Results.