The market-leading, trusted solution for processing, analyzing, and reporting adverse event cases originating in premarket and post-market drugs, biologics, vaccines, devices, and combination products. Transform your case management efficiency with innovative capabilities, such as built-in automation, workflow optimization, and conditional touchless processing.

Expertly manage rapidly increasing caseloads and changing regulations.

Trusted safety case management

Automate case processing steps

Built-in Argus automation features—for intake, case prioritization, field validations, letters, action items, coding, listedness, narratives, case lock, submission, and archiving—can reduce manual work by 50% or more.

Maintain safety compliance

You can depend on Argus, a mature, reliable solution providing proven compliance with drug, vaccine, and device regulations and standards in all regions of the world, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP.

Gain insights into the data

Argus Advanced Cloud includes Oracle Analytics, a powerful, flexible, AI-powered solution that empowers users to uncover new insights and make faster, more informed business decisions.

Blog post

Argus and the future of pharmacovigilance

Since 1997, Oracle Argus has played a significant role in shaping medicinal product safety and now leads the way to next-generation multivigilance through data science-based innovation.

Automation is key to meeting demands in pharmacovigilance

Increasing efficiency in safety case processing

With so many new ways to report adverse events, companies can access more data on drug safety than ever before. As the number of adverse events rises, it’s crucial to have a system like Argus that can provide fast, high-quality insights at scale to drive the company—and industry—forward. Learn why automation is key in addressing these challenges.

Argus is industry-proven worldwide

More than10Mcases processed annually

More than400customers globally

More than70%of drug ICSRs in FDA FAERS

More than90%of vaccine ICSRs in FDA VAERS

4C Pharma considers Oracle Argus the gold standard in safety

How have Oracle's cloud offerings matured? What kind of service can customers expect within the Oracle SaaS suite? Hear from Steve Miranda, executive vice president for Oracle Applications Product Development, as he sits down with Constellation Research analyst Ray Wang.

Argus customer stories

See all customer stories

Discover how our customers use Oracle Argus for safety case management.


Celebrating Argus’s 25th anniversary

In the 25 years since the birth of Argus, evolving technologies and pharmaceutical standards have significantly enhanced medicinal product safety. Current innovations in data science promise even greater future achievements. Discover key Argus milestones that have improved safety, and learn how Oracle continues to lead the way to next-generation multivigilance.

Find resources and more

Oracle Safety Consortium

Engage with the Oracle Safety Consortium and participate in meetings, events, roundtable discussions, and working groups to accelerate safety solutions and help shape the future of the Argus, Empirica, and Safety One Intake solutions.

Safety One platform

Learn how the Safety One platform addresses industry challenges by detecting risks earlier, automating processes, and increasing compliance with unified multivigilance.

Safety innovation timeline

Evolving technologies and pharmaceutical standards have significantly enhanced medicinal product safety in the last few decades, with innovations in data science promising even greater future achievements. Discover key milestones that have improved safety, and learn how Oracle continues to lead the way to next-generation multivigilance.

Oracle safety and pharmacovigilance

Medicinal product safety teams face enormous pressure to control ever-increasing caseloads, new sources of signal detection data, and changing regulations—all with flat budgets and resources. See how Oracle addresses these pharmacovigilance challenges.

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