SafeVig Aggregate Reports
Streamlining Pharmacovigilance Reporting & Safety Analysis
Automate, analyze, and manage PSURs, RMPs, and safety reports—compliantly and efficiently.
Automated Report Generation
- • Aggregates data from clinical, post-marketing, and global sources
- • Fully compliant, customizable PSUR & RMP templates
- • AI-driven analytics for trend detection
Real-Time Data Integration
- • Multi-source consolidation for holistic safety view
- • Dynamic updates for always-current reports
- • Supports instant insights for regulatory review
Regulatory Compliance & Standardization
- • Built to meet FDA, EMA, PMDA, and ICH requirements
- • Version control and full audit trails
- • 21 CFR Part 11 electronic record compliance
Risk-Benefit Evaluation
- • AI-powered risk scoring and benefit assessment
- • Automated reporting for faster review cycles
- • Supports compliance and internal decisions
Audit-Ready & Transparent
- • Comprehensive logs and revision tracking
- • Inspection-ready at any time
- • Supports seamless regulatory and internal audits
Notifications & Collaboration
- • Real-time alerts for deadlines and tasks
- • Collaborative assignment and progress tracking
- • Keeps safety teams aligned and on track
Why Choose SafeVig Aggregate Reports?
- Automated Efficiency: Reduces manual work, accelerates reporting cycles, and cuts resource burden.
- Regulatory Compliance: Seamless, audit-ready, and globally aligned.
- Comprehensive Analysis: Multi-source data unification for deep, actionable insights.
- Proactive Risk Management: AI-powered analytics spot emerging trends before they become risks.
- Transparent & Scalable: Tracks every change, adapts to organizations of any size.
- Cost & Resource Savings: Minimizes manual labor and enables your team to focus on strategic safety activities.
Empowering Pharmacovigilance with SafeVig Aggregate Reports
Automate your aggregate reporting lifecycle—boosting compliance, insights, and team productivity.
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