Adverse Event Tracking

Comprehensive Safety & Vigilance Monitoring

Protect patients and ensure regulatory compliance

Advanced Adverse Event Management

Our adverse event tracking system provides comprehensive safety surveillance and regulatory reporting capabilities for medical devices, pharmaceuticals, and life sciences organizations to monitor product safety and ensure patient protection.

⚠️ 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

FDA Requirements: 21 CFR Part 803 (MDR), 21 CFR Part 314.80 & 314.98 (Drug AE reporting)

EU MDR/IVDR: Post-market surveillance and vigilance reporting

ICH Guidelines: E2A, E2B(R3), E2C(R2), E2D, E2E compliance

ISO Standards: ISO 13485, ISO 14971 risk management integration

Global Markets: Health Canada, TGA, PMDA, and other international authorities

Key Capabilities

Expedited Reporting: Automated identification and processing of serious adverse events requiring expedited submission

Literature Monitoring: Systematic literature review and adverse event extraction from scientific publications

Duplicate Detection: Intelligent algorithms to identify and manage duplicate case reports

Data Mining: Advanced analytics for signal detection and benefit-risk assessment

Audit Trail: Complete electronic documentation and 21 CFR Part 11 compliant audit trails

Integration: Seamless connectivity with complaint management, CAPA, quality systems, and clinical trial databases