Signum
The Next-Generation Signal Detection and Risk Management Platform
Proactively detect, evaluate, and act on safety signals—before they escalate.
Signum transforms how Pharmacovigilance and Safety teams manage signal detection with AI-driven automation, real-time analytics, and a fully compliant risk management framework.
What is Signum?
Signum is an advanced signal detection and management software built for today’s dynamic regulatory and scientific landscape. Designed for pharmaceutical companies, CROs, and biotech firms, Signum automates and streamlines every stage of the signal lifecycle—from detection to evaluation, validation, and reporting.
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Whether you're managing ongoing benefit-risk assessments, monitoring aggregate data, or responding to emerging safety concerns, Signum empowers your teams to make faster, smarter, and compliant decisions.
SALVUS COMPLAINT TO 10+ PHARMACEUTICAL REGULATORY AGENCIES
Core Capabilities
Automated Signal Detection
Continuous surveillance of internal and external data sources Statistical algorithms and disproportionality analysis (PRR, ROR, IC)
Integration with global safety databases (e.g., VigiBase, FAERS)
Dynamic Signal Evaluation
Visual signal prioritization dashboards
Trend analysis and data visualization
AI-generated summary reports for rapid review
Risk Management Planning
Signal validation and documentation workflows
Built-in Risk Management Plan (RMP) modules
Audit-ready trail of all evaluations and decisions
Global Signal Intelligence
Aggregate report integration (PSUR, PBRER)
Literature monitoring alignment with GVP Module IX
Custom alerts and early warnings for new safety concerns
Compliance-First Architecture
ICH E2E, GVP Module IX and FDA Signal Detection Guidelines 21 CFR Part 11-compliant electronic signatures and audit trails Validated environment for secure, traceable decision-making
Automated Duplicate Check
The platform includes an advanced duplicate detection feature, which automatically identifies and flags duplicate entries, ensuring data integrity and reducing redundancy in literature reviews.
Comprehensive Literature Review Support
Crypta supports both Global and Local Literature Reviews, providing users with a robust framework for comprehensive data analysis. The platform's flexibility allows for tailored reviews that meet the specific needs of different regulatory environments.
Highly Customizable Workflows
Recognizing the diverse requirements of its users, Crypta offers highly customizable workflows. These workflows can be tailored to fit specific organizational needs, ensuring seamless integration into existing processes.
Key Benefits
Faster Time-to-Insight
Identify and act on critical safety signals within hours, not weeks
Seamless Collaboration
Shared signal review dashboards for global teams
Consistent Risk Evaluation
Standardized workflows ensure accuracy and traceability
Data-Driven Safety
Real-time visualizations and AI-powered prioritization
Regulatory Confidence
Full transparency and documentation from detection to closure
INTEGRATED PLATFORM
Integrations
Signum integrates effortlessly with:
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Salvus (ICSR Management)
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Crypta (Literature Monitoring)
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Custom APIs for data lakes, EDC, or signal review boards