Adverse Event Tracking

Protect patients and ensure regulatory compliance

Advanced Adverse Event Management

⚠️ Event Capture

Multi-source adverse event intake from healthcare providers, patients, clinical studies, and post-market surveillance with standardized data collection.

🎯 Risk Assessment

Automated risk scoring and classification based on severity, frequency, and potential patient impact with intelligent triage and prioritization.

📊 Signal Detection

Advanced analytics and statistical algorithms to identify safety signals, emerging trends, and patterns requiring investigation or regulatory action.

🔍 Case Management

Complete case lifecycle management from intake through investigation, medical review, causality assessment, and closure with full traceability.

📋 Regulatory Reporting

Automated preparation and submission of mandatory reports including FDA MedWatch, MDR, PSUR, DSUR, and other global regulatory requirements.

🏥 Medical Review

Integrated medical and scientific assessment workflows with causality determination, coding (MedDRA, WHODrug), and literature surveillance.

⏰ Compliance Timelines

Automated deadline tracking and escalations to ensure timely regulatory submissions and compliance with reporting requirements worldwide.

🌍 Global Standards

Support for international regulatory requirements including FDA, EMA, PMDA, Health Canada, and ICH E2B transmission standards.

📈 Analytics Dashboard

Real-time safety metrics, trending analysis, and executive dashboards for informed decision-making and proactive risk management.

Regulatory Compliance

Key Capabilities

Industry Solutions

Specialized adverse event tracking for:

Enhance Your Safety Surveillance Program

Contact us to discuss your adverse event tracking and pharmacovigilance needs

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Organizations that invest in professional adverse event tracking solutions gain a significant operational advantage in their quality management and compliance capabilities, positioning themselves ahead of competitors who rely on fragmented or manual approaches to critical business processes. AGM Network's adverse event tracking services are engineered to deliver rapid time to value while building a sustainable foundation for continuous improvement and digital transformation across the enterprise. Our practice integrates adverse event tracking with quality management systems to deliver comprehensive solutions that address both immediate operational needs and long-term strategic objectives. The synergy between adverse event tracking and quality assurance unlocks advanced capabilities that enable predictive insights, automated workflows, and intelligent resource optimization across business units. AGM Network's compliance management teams ensure that every implementation follows rigorous quality standards, and our risk management services provide the ongoing support needed to maximize your investment. Explore our complete services portfolio or connect with our experts to learn how adverse event tracking can drive transformational outcomes for your enterprise.