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EXTEDO PV-Works

The All-in-One Pharmacovigilance Solution.

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Overview

EXTEDO PV-Works is an all-in-one pharmacovigilance solution that helps life sciences companies manage the entire drug safety lifecycle. The platform includes features for case management, regulatory reporting, signal detection, and document management. PV-Works is designed to be user-friendly and can be deployed in the cloud or on-premise.

✨ Key Features

  • Adverse Event Case Management
  • Global regulatory reporting (E2B R3)
  • Signal Detection and Management
  • Document Management
  • User-friendly interface
  • Cloud or on-premise deployment

🎯 Key Differentiators

  • Strong integration with regulatory submission tools
  • Focus on the European market
  • Flexible deployment options

Unique Value: An integrated solution for pharmacovigilance and regulatory submissions, streamlining the entire process.

🎯 Use Cases (4)

Pharmacovigilance for small to large life sciences companies Integrated regulatory and safety management Compliance with global regulations Post-marketing surveillance

✅ Best For

  • Integrated pharmacovigilance and regulatory submission management

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Organizations that do not require integration with regulatory submission tools

🏆 Alternatives

Ennov PV-Works Oracle Argus Safety Veeva Vault Safety

Offers tighter integration with regulatory submission software compared to other PV solutions.

💻 Platforms

Web API

🔌 Integrations

EXTEDO eCTDmanager EDC systems Third-party systems via API

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support
  • ✓ Dedicated Support (Enterprise tier)

🔒 Compliance & Security

✓ HIPAA ✓ BAA Available ✓ GDPR ✓ SSO ✓ FDA 21 CFR Part 11 ✓ GxP

💰 Pricing

Contact for pricing

Free tier: NA

Visit EXTEDO PV-Works Website →