Oracle Life Sciences

Overview

Oracle's life sciences division develops Argus Safety (Safety One Argus), an industry-standard pharmacovigilance case management platform supporting intake, case processing, signal detection, and global regulatory reporting for drugs, biologics, vaccines, and devices. Widely used by pharma sponsors and CROs for both pre- and post-market safety surveillance.

Notable

Argus is widely considered the incumbent gold-standard safety database in pharmacovigilance, compliant with ICH E2B(R3), FDA, and PMDA reporting standards.

Key services

safety case management (Argus)
regulatory reporting (E2B R3, eVAERS, eMDR)
signal detection
safety workflow automation
MedDRA/WHO Drug coding

Subcategories

Pharmacovigilance Software
Safety Systems
EHR Data
RWE Studies
HEOR Analytics

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Sources

https://www.oracle.com/life-sciences/safety-solutions/
https://www.oracle.com/life-sciences/safety-solutions/argus-safety-case-management/
https://www.oracle.com/life-sciences/real-world-evidence/
https://www.oracle.com/news/announcement/cerner-enviza-collaborates-with-fda-to-develop-innovative-ai-tools-2023-04-10/