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Medicinal product safety teams are under enormous pressure to control ever-increasing caseloads, new sources of signal detection data, and changing regulations—all with flat budgets and resources. What if you could alleviate this pressure on multivigilance activities, while improving efficiency and strengthening compliance?

Collaborate with industry peers to advance safety.

Celebrating 25 years of safety innovation

Birth of Argus and Empirica

Birth of Argus and Empirica

Argus and Empirica are among the first safety case management and signal management solutions, helping end pharmacovigilance’s reliance on paper and ushering in the use of digital technology in the industry.

Gamma Poisson Shrinker (GPS) algorithm

Gamma Poisson Shrinker (GPS) algorithm

Dr. Bill DuMouchel publishes Empirica‘s Gamma Poisson Shrinker (GPS) algorithm in The American Statistician, after inventing it in collaboration with the FDA.

Multi-Item Gamma Poisson Shrinker (MGPS) algorithm

Multi-Item Gamma Poisson Shrinker (MGPS) algorithm

Extending the GPS model, Dr. DuMouchel invents Empirica’s MGPS signal detection algorithm, which allows for product interactions.

NetForce acquisition and Argus and Empirica advancements

NetForce acquisition and Argus and Empirica advancements

Oracle acquires NetForce for its pharmacovigilance capabilities. Argus 3 is released as a web application and adds the E2B(R2) report, an affiliate module, and a Japan module. Empirica 3 is released and expands the customer base to include biopharmas.

Continued advancement and SiteWorks acquisition

Continued advancement and SiteWorks acquisition

Argus 4 and Empirica 4 are released with major feature enhancements, and Oracle acquires SiteWorks for its clinical R&D capabilities.

Argus and Empirica lead their markets

Argus and Empirica lead their markets

Argus becomes the market leader for case management, and Empirica, in its fifth release, becomes the market leader for signal management.

Extended Logistic Regression (ELR) algorithm

Extended Logistic Regression (ELR) algorithm

Empirica 6 is released with the ELR algorithm and other major enhancements.

Relsys and Argus acquisition

Relsys and Argus acquisition

Oracle acquires Relsys for its pharmacovigilance capabilities, and Argus becomes an Oracle product. Oracle Argus 5 is then released with new key features, including updates to the case form and reports.

Phase Forward and Empirica acquisition

Phase Forward and Empirica acquisition

Oracle acquires Phase Forward for its pharmacovigilance and clinical R&D capabilities, bringing Empirica into the Oracle product family.

Groundbreaking new Argus modules

Groundbreaking new Argus modules

Oracle announces Argus Cloud, Argus Analytics, and Argus Multitenancy. The new products streamline processes, lower costs, and provide better data insights.

Regression-Adjusted Gamma Poisson Shrinker (RGPS) algorithm

Regression-Adjusted Gamma Poisson Shrinker (RGPS) algorithm

Oracle Empirica’s RGPS algorithm is invented by Dr. Bill DuMouchel and Dr. Rave Harpaz, combining the advantages of the MGPS and ELR algorithms into one hybrid method.

Argus adds the Periodic Benefit Risk Evaluation Report (PBRER)

Argus adds the Periodic Benefit-Risk Evaluation Report (PBRER)

After the ICH publishes PBRER Step 4, Oracle adds it to the Argus report library.

New reports and integrations in Argus

New reports and integrations in Argus

Oracle Argus incorporates E2B(R3), eVAERS, eMDR, and J-DSUR reports and integrates with the Oracle B2B for EDI gateway.

Argus expands compliance and Empirica extends algorithms

Argus expands compliance and Empirica extends algorithms

Argus now supports EMA E2B(R3), PMDA E2B(R3), and IDMP. Empirica adds RGPS, IC, case scoring, and increased frequency algorithms.

New medical device report and dictionary formats in Argus

New medical device report and dictionary formats in Argus

Argus adds the MIR report as well as the WHODrug B3 and C3 formats.

Update to the FDA’s medical device report

Update to the FDA’s medical device report

Argus incorporates the eMDR(R2) report, the new version of eMDR.

Empirica 9 and Argus Japan enhancements

Empirica 9 and Argus Japan enhancements

Empirica launches a new user interface, and Argus adds two new reports for Japan: PSR and ReSD.

Birth of Safety One Intake

Birth of Safety One Intake

Supporting the need to achieve greater efficiencies in case processing, Oracle releases its first AI-powered pharmacovigilance application: Oracle Health Sciences Safety One Intake.

Oracle acquires Cerner

Oracle acquires Cerner

Oracle acquires Cerner, a major supplier of health information systems, strengthening the tie between real-world data and the industry-leading cloud platform to develop solutions that deliver better health insights.

Paving the way

Paving the way to improved safety

Using cutting-edge technologies and industry expertise, Oracle’s safety data science team continues to apply the right solutions to solve specific challenges, deliver value, and evolve the Safety One Platform (PDF).


Oracle safety applications are industry-proven worldwide

More than400customers globally

More than80%of top pharma companies use them

More than10Mcases processed annually

More than70%of drug ICSRs in FDA FAERS

More than90%of vaccine ICSRs in FDA VAERS

More than90%proven efficiency gains

Ensure compliance from clinical trials through post-marketing surveillance

Transform your case intake process

Reduce processing time by 90% when using Oracle Health Sciences Safety One Intake Cloud Service with Oracle Argus.

Explore Safety One Intake

Automate your safety case workflow

Relieve the pressure of growing caseloads while maintaining compliance with global regulations and standards by automating safety case management.

Explore Argus for safety case management

Confidently detect, analyze, and manage safety signals

Automate safety-signal detection with proven algorithms developed by world-class statisticians and data scientists.

Explore Empirica for safety signal management

Make faster, better safety decisions

Empower business users, data engineers, and data scientists to process relevant data, evaluate predictions, and make quick, accurate decisions.

Explore Oracle Analytics

“We rely on technologies like Oracle Argus Cloud to help ensure that we are making safety decisions, reduce risk, and help ensure global compliance—so that we can focus on delivering therapies that will improve the quality of life of patients.”

Michelle Kim

CEO, GemVax & KAEL

How our customers experience Oracle for pharmacovigilance

See all customer stories

Oracle named a Leader by IDC MarketScape for life science R&D pharmacovigilance solutions

Michael McCann, Global Vice President of Sales, Alliances, and Channels

The life sciences industry is recognizing the importance of adopting new technologies in pharmacovigilance.

Read the complete post

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.

Oracle Health Sciences Consulting

Every organization has different requirements and expectations that drive their technology investments, which must be met to ensure success. Oracle Health Sciences Consulting is here to support that journey and make sure you get the most out of your technology investment.

Automation is key to meeting demands in pharmacovigilance

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 rise, it’s crucial to have a system 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.

Unmasking safety signals

In this episode of The Latest Dose podcast, Dr. Joseph (Joe) Tonning, medical and pharmaceutical consultant at ThinkTrends and practicing physician at Your Health Concierge, discusses signal detection, safety surveillance, and analytic methods to identify potential drug and vaccine safety risks. The masking effect, a statistical issue, and how to handle it are also covered.

Exploring the changing approach to drug safety

While pharma has traditionally seen the pharmacovigilance process as a cost center, it’s now a foundational component for any organization. Discover how technology and regulations over the last century have affected present-day pharmacovigilance practices.

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