SafeVig Signal Solution is a cutting-edge, AI-driven Signal Management System designed to revolutionize pharmacovigilance by detecting signals with precision, speed, and efficiency. Built on advanced machine learning algorithms and Natural Language Processing (NLP), SafeVig enhances signal detection and management through its predictive capabilities. This solution integrates various data sources, offering a comprehensive view of product safety in real time. With SafeVig's seamless dashboard interface, users gain intuitive access to both product-level and aggregate-level safety information. Key innovations like automatic narrative generation and an interactive dashboard with drill- down visual analytics make signal management a streamlined and insightful experience. Delivered as a SaaS platform, SafeVig ensures hassle-free automatic updates and compliance, with no additional costs for patching, validation, or regression testing.
Key Features
Auto-Generation of Narratives:
Automatically generates detailed aggregate analysis narratives for signal validation, enhancing causality assessment accuracy.
Comprehensive Audit Trail:
Ensures inspection readiness with a fully integrated audit trail, documenting every action for compliance.
Interactive Visual Analytics:
Intuitive drill-down visualizations facilitate faster decision-making, allowing users to analyze data in-depth.
Global Health Authority Integration:
Access data from global health authority databases (e.g., FAERS, Health Canada, TGA) for informed safety decisions.
Automated Signal Escalation Workflow:
Signals are automatically escalated based on predefined timelines, with responsibilities clearly assigned.
Value Proposition
Integrated Signal Detection:
Combines both internal and external signal sources by product, providing a holistic view of safety data.
Significant Time Savings:
Machine-assisted causality assessment reduces signal validation time by up to 70%, accelerating safety evaluations.
Compliance Optimization:
Automatically updates timelines in line with Standard Operating Procedures (SOPs), ensuring regulatory compliance.
Automated Signal Evaluation Reports:
Reports are automatically generated and assigned, minimizing manual intervention and reducing error.
Efficiency Gains:
SafeVig reduces the total time from signal detection to evaluation by at least 60%, allowing for faster, more accurate responses to safety concerns.
Delivery Model
SafeVig is delivered via a secure, scalable Software-as-a-Service (SaaS) platform. Users benefit from continuous updates through an automated patching process, keeping the system up-to-date with the latest features and regulatory changes, without the need for manual validation or additional costs.
SafeVig Signal Solution empowers organizations to manage pharmacovigilance more effectively, reducing risk while enhancing safety monitoring and decision-making processes.
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