Soterius Signal Detection & Management
Proactive Signal Detection and Risk Management.
Overview
Soterius offers specialized solutions focused on the critical pharmacovigilance process of signal management. This includes services and technology for signal detection, validation, prioritization, and assessment. They help companies proactively monitor safety data from various sources to identify potential new risks or changes in known risks, ensuring compliance with global regulations like GVP Module IX.
✨ Key Features
- Signal detection from various data sources
- Signal validation and prioritization
- Risk assessment and management planning (RMP)
- Regulatory compliance with GVP Module IX
- Benefit-risk assessment
- Pharmacovigilance consulting services
🎯 Key Differentiators
- Deep specialization and focus on signal and risk management
- Combination of expert consulting services with technology
- Agility and customized approach for clients
Unique Value: Provides deep, specialized expertise in signal and risk management, helping companies ensure compliance and proactively manage the benefit-risk profile of their products.
🎯 Use Cases (3)
✅ Best For
- Supporting pharmaceutical companies in establishing and running a compliant and efficient signal management system.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Companies looking for a single, end-to-end software for ICSR case processing and submissions.
🏆 Alternatives
Offers a more focused and expert-driven service for signal management compared to the broader, all-in-one software platforms.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Phone Support
- ✓ Dedicated Support (Varies tier)
🔒 Compliance & Security
💰 Pricing
Free tier: NA
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