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.
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
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
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
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
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 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
Empirica 6 is released with the ELR algorithm and other major enhancements.
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
Oracle acquires Phase Forward for its pharmacovigilance and clinical R&D capabilities, bringing Empirica into the Oracle product family.
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
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)
After the ICH publishes PBRER Step 4, Oracle adds it to the Argus report library.
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 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
Argus adds the MIR report as well as the WHODrug B3 and C3 formats.
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 launches a new user interface, and Argus adds two new reports for Japan: PSR and ReSD.
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, 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 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 IntakeAutomate 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 managementConfidently 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 managementMake 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
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Watch the 4C Pharma story (2:35)
4C Pharma Solutions enjoys better, more concise safety case processing without errors
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Watch the Avance Clinical story (6:49)
Avance Clinical provides broader pharmacovigilance services by selecting Argus
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Watch the CMIC story (2:44)
CMIC gains more efficient operations using Oracle Argus
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Watch the Syneos story (1:54)
For more than two decades, Syneos has relied on Oracle for safety case management
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 postFind 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.
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.
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