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Oracle Argus

Comprehensive pharmacovigilance platform for managing adverse event cases.

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Overview

Oracle Argus is a market-leading pharmacovigilance platform that enables pharmaceutical companies and CROs to manage the entire drug safety lifecycle. It facilitates compliance with global regulations by providing robust case management, advanced analytics, and automated reporting capabilities for both clinical and post-marketing safety data.

✨ Key Features

  • End-to-end Case Management (ICSR)
  • Global Regulatory Reporting (E2B R3)
  • Periodic Reporting (PSUR, PADER, DSUR)
  • Signal Detection and Management
  • Integration with Clinical Systems
  • MedDRA and WHO-DD Coding

🎯 Key Differentiators

  • Long-standing market leader with a large user base
  • Deep integration with Oracle's life sciences ecosystem
  • Robust and highly configurable for complex enterprise needs

Unique Value: Oracle Argus provides a highly reliable and compliant solution for managing complex, high-volume pharmacovigilance operations at a global scale.

🎯 Use Cases (4)

High-volume adverse event case processing Global regulatory submissions to agencies like FDA and EMA Safety signal detection and risk management Management of clinical trial and post-marketing safety data

✅ Best For

  • Enterprise-scale pharmacovigilance for global pharmaceutical companies
  • Safety database for CROs managing multiple sponsors

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Small startups with very low case volumes
  • Organizations requiring a simple, non-configurable solution

🏆 Alternatives

ArisGlobal LifeSphere Safety Veeva Vault Safety IQVIA Safety Suite

While some alternatives may be more modern in their UI, Argus is considered the industry benchmark for comprehensive, compliant case processing and has a proven track record.

💻 Platforms

Web API

🔌 Integrations

Oracle Clinical Oracle Health Sciences InForm API

🛟 Support Options

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

🔒 Compliance & Security

✓ SOC 2 ✓ HIPAA ✓ BAA Available ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ GxP ✓ FDA 21 CFR Part 11 ✓ ICH E2B (R2/R3)

💰 Pricing

Contact for pricing
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