Safety and Pharmacovigilance

What if you could support innovation in your multivigilance activities, while improving efficiency and strengthening compliance? Whether it’s a signal management, post-authorization, or case management solution you need, we have you covered.


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.

1997
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.

1999
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.

2000
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.

2002
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.

2004
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.

2005
Extended Logistic Regression (ELR) algorithm

Extended Logistic Regression (ELR) algorithm

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

2007
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.

2009
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.

2010
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.

2011
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.

2012
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.

2013
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.

2015
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.

2016
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.

2017
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.

2018
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.

2019
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 Life Sciences Safety One Intake.

2020
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.

2022
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).

Today

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

Detect risks, automate processes, increase compliance.

Ensure compliance from clinical trials through post-marketing surveillance

Meet your post-authorization commitments

From design to execution, our solutions let you establish evidence for safety and effectiveness in a real-world setting.

Explore post-authorization safety and efficacy studies

Develop plans to evaluate and mitigate medical risk

Risk evaluation strategies and plans ensure that medical risks are detected early and minimized while benefits are optimized.

Explore risk benefit optimization

Transform your case intake process

Reduce processing time by 90% when using Oracle Life 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

Vamos começar com o Oracle Life Sciences.


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