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).
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 IntakeMake 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 ManagementConfidently 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
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.
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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.
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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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