SafeVig Signal
Advanced Signal Detection & Risk Management
AI-powered platform for proactive signal detection, risk assessment, and regulatory compliance across the product safety lifecycle.
Automated Signal Detection
- • Rapidly analyzes large datasets using AI & ML
- • Detects early safety signals in clinical and real-world data
- • Multivariate analysis across frequency, demographics, usage
Advanced Risk Assessment & Prioritization
- • Assigns composite risk scores to signals
- • Continuous benefit-risk assessments
- • Helps prioritize follow-up actions
Comprehensive Data Integration
- • Centralizes clinical, post-marketing, and literature data
- • Multi-source data fusion for holistic safety views
- • Real-time, global reporting integration
Signal Confirmation & Medical Review
- • AI-powered validation using literature and trial data
- • Expert clinical review workflows
- • Reduces false positives, ensures robust action
Regulatory Compliance & Reporting
- • Automated ICSR & PSUR report generation
- • Audit-ready logs aligned with 21 CFR Part 11
- • Global compliance with FDA, EMA, PMDA & more
Real-Time Alerts & Stakeholder Notifications
- • Custom alerts for signal detection and status changes
- • Instantly notifies teams and stakeholders
- • Ensures rapid response and transparency
Why Choose SafeVig Signal?
- Early Detection of Safety Risks: AI-powered insights flag risks before escalation.
- Enhanced Regulatory Compliance: Automated, audit-ready reporting streamlines workflows.
- Real-Time Insights: Prioritized data empowers informed safety decisions.
- Seamless Integration & Scalability: Works with your existing safety platforms, large or small.
- AI-Driven Accuracy: Reduces false positives and improves detection over time.
- Comprehensive Data Security: Encryption, access controls, and full audit trails ensure compliance.
Empowering Safety with SafeVig Signal
Achieve excellence in pharmacovigilance with automated signal detection, real-time analytics, and regulatory-ready features.
Request a Demo
