NextTrial Total Safety Intelligence

End-to-End Safety Intelligence and Oversight

Expedite case processing, elevate quality and compliance, generate knowledge-graph–powered safety insights, and detect and act on signals sooner with NextTrial Total Safety Intelligence.

Delivering advanced safety analytics and AI-driven insights across diverse safety sources, the solution empowers teams to improve efficiency, strengthen safety profiles, and ensure regulatory readiness.

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Benefits

Faster Case Processing

Automate data intake, capture, triage, and routing into the case processing system to reduce turnaround times, minimize manual errors and ensure timely submissions.

Advanced Analytics and Signal Management

Enable end-to-end safety operations visibility, simplify aggregate reporting and manage signals efficiently, transforming raw safety data into actionable insights — powering Strategic PV.

Elevate Quality and Compliance

Reduce errors, monitor compliance with real-time KPIs and inspection-ready dashboards, and drive continuous improvement through structured workflows and effective CAPA management.

Comprehensive Safety Oversight

Ensure proactive benefit–risk management across the full product safety lifecycle, delivering end-to-end insight into safety profile from clinical research to real-world use.

Features

Automated Case Intake

Ingest ICSRs from E2B (R3), AE forms, literature, call centers, and clinical systems with automated parsing, de-duplication, validation, and MedDRA/WHO-DD coding. AI-based triage assigns priority and routes cases to the safety system with minimal manual intervention.

Advanced Signal and Analytics

Apply statistical and knowledge-graph–based signal detection across internal and external safety sources. Automate signal review, generate line listings, and deliver real-time metrics to support faster review, automated assessment, and strengthened safety profiles.

Real-time Quality and Compliance

Configurable pipelines unify safety data and apply automated checks for lateness, completeness, and quality issues. Tailored workflows manage Root Cause analysis and CAPA, while real-time dashboards provide global KPI visibility to support continuous improvement and inspection readiness.

End to end safety profile lifecycle

Consolidates safety data across clinical trials, post-marketing surveillance, and real-world evidence into a unified product safety view. Benefit-risk trends, emerging patterns, and population-level insights support proactive safety governance over time.