EXTEDO SafetyEasy (PV-Works)
The all-in-one pharmacovigilance solution for ICSRs, e-reporting, and multivigilance.
Overview
EXTEDO's SafetyEasy is a pharmacovigilance software designed to streamline the processing of safety cases and vigilance data. It provides a central repository for all safety data, including clinical trials and post-market reports. The platform ensures compliance with global regulations like E2B(R3) and supports the generation of key regulatory documents. Its focus is on user-friendliness, quick deployment, and efficiency, making it a popular choice for small to mid-sized pharma, biotech, and generics manufacturers.
✨ Key Features
- Full ICSR case management
- E2B(R3) and HL7 eMDR compliance
- Aggregate report generation (PSUR, PBRER, DSUR)
- Workflow optimization with dashboards and notifications
- Multivigilance support (drugs, devices, cosmetics)
- Rapid deployment and pre-validated system
🎯 Key Differentiators
- Focus on user-friendliness and rapid implementation
- Strong regional presence and expertise in European regulations
- Modular approach that integrates well with other EXTEDO regulatory products
Unique Value: Offers a compliant, user-friendly, and rapidly deployable pharmacovigilance solution tailored to the needs of small and mid-sized life sciences companies.
🎯 Use Cases (3)
✅ Best For
- Used by generics manufacturers and biotech companies to achieve rapid compliance with global PV reporting standards.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Large multinational corporations with extremely high case volumes and complex, custom workflow needs might require a more scalable enterprise solution.
🏆 Alternatives
Simpler to implement and more cost-effective than large-scale enterprise systems, while offering comprehensive compliance features.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Phone Support
- ✓ Dedicated Support (Varies tier)
🔒 Compliance & Security
💰 Pricing
Free tier: NA
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