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Pharmacovigilance

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.

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 Health 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

Ensure compliance from clinical trials through post-marketing surveillance

Automate your safety case processing

Reduce processing time by 50% while improving accuracy and compliance through AI-powered digital case intake.

Explore Safety Case Intake

Make faster, better safety decisions

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

Explore Argus—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—Safety Signal Management

“When you have Argus, you know you can handle everything from small Phase I to large Phase III and IV trials.”

Timo Toivonen

Vice President, Services, Crown CRO

How our customers experience Oracle for pharmacovigilance

Explore more customer stories
For over two decades Syneos has relied on Oracle for safety case management
4C Pharma Solutions enjoys better, more concise safety case processing without errors
PharSafer depends on Oracle Argus Cloud to process, analyze, and report adverse event cases

Are you prepared for regional, post-market medical device safety regulations?

Una Kessi, Oracle Product Management, Safety and Pharmacovigilance

Medical device safety reporting requirements vary by region—make sure you are up to date on the regulations and are prepared to comply.

Read the complete post

Find resources and more

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.

Is AI the key to speed and efficiency in pharmacovigilance?

In an effort to bolster pharmacovigilance programs, pharma companies have succeeded in gathering massive amounts of data—so much so that they have found themselves struggling under the weight of it, particularly around adverse event reports. Is AI the solution?

Addressing the data challenges of pharmacovigilance

Hear how pharmacovigilance managers are addressing the increase in volume and variety of incoming drug safety data.

Collaborate with industry peers to advance safety

Discuss best practices in pharmacovigilance, hear about harmonized approaches to meeting new regulatory requirements, and stay current with the Oracle safety product strategy and roadmap.

Get started with Oracle Life Sciences


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