• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Life Sciences
  • Investments
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage

Oracle Strengthens Pharmacovigilance Solutions with AI-Powered Enhancements

by Jasmine Pennic 07/11/2024 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

What You Should Know: 

– Oracle announced significant updates to its Argus and Safety One Intake solutions, bolstering its pharmacovigilance portfolio with AI-powered features. 

– These AI enhancements cater to the evolving needs of life science organizations, allowing them to navigate increasingly complex regulatory landscapes and manage rising adverse event caseloads.

Enhanced Efficiency and Regulatory Compliance

The new features prioritize efficiency and regulatory compliance, streamlining workflows for pharmaceutical and medical device companies, as well as clinical research organizations (CROs). The updates address specific requirements, including:

  • Data Redaction for Europe: Upholding European data privacy regulations, redaction capabilities for Personally Identifiable Information (PII) are updated to comply with EMA instructions for ICSRs (Individual Case Safety Reports) transmitted internationally.
  • Medical Device Reporting: The solution adheres to the latest FDA CDRH (Center for Devices and Radiological Health) guidance updates, ensuring compliance for medical device reporting obligations in the U.S. and Japan.
  • Global Harmonization: CIOMS-I report mappings are harmonized with E2B reports, enhancing report accuracy and comprehensiveness.

Improved Argus Functionality

Oracle Argus benefits from several key updates:

  • Smart Duplicate Search: This intelligent algorithm pinpoints duplicate cases with ease, reducing manual effort and accelerating case management.
  • Enhanced End-of-Study Unblinding: A user-friendly interface empowers bulk unblinding of cases, boosting operational efficiency.
  • Streamlined Reporting: Updated report mappings simplify reporting processes and ensure compliance with current regulations.

Safety One Intake: Automating Intake with AI

Safety One Intake, an AI-powered solution, automates the ingestion of safety data from source documents into Argus. This eliminates manual data entry, saving significant time and resources. The latest update introduces:

  • Automated Email Intake: Safety reports automatically flow from email inboxes, extracting relevant information from email subject lines and attachments. This streamlines intake procedures and reduces manual intervention.
  • CRO Support: Catering to the needs of CROs, Safety One Intake can manage multiple enterprises. The system effortlessly maintains configurations and intake processing activities for each client, ensuring data segregation and flexibility.

Availability

These new capabilities are available for immediate use, empowering life science organizations to navigate the ever-changing pharmacovigilance landscape with greater efficiency and regulatory clarity.

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: Artificial Intelligence

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Interview

The AI Paradox in Healthcare: Notable CEO Shares Why Moving Too Slowly is a Greater Risk

Most-Read

KLAS Report: Epic's Native Ambient Speech Tool Reshapes Customer AI Strategies

KLAS Report: Epic’s Native Ambient Speech Tool Reshapes Customer AI Strategies

Epic Unveils MyChart Central and New APIs to Advance Interoperability at Open@Epic

Epic Outlines Roadmap for Next-Generation Data Sharing at Open@Epic

Epic Launches Comet: A New AI Platform to Predict Patient Health Journeys

Epic Launches Comet: A New AI Platform to Predict Patient Health Journeys

RevSpring to Acquire Kyruus Health, Creating a Unified Patient Experience

RevSpring to Acquire Kyruus Health, Creating a Unified Patient Experience

Oracle Confirms Layoffs in Kansas City

Oracle Confirms Layoffs in Kansas City

Philips Future Health Index 2025: AI and Digital Tech Can Help Solve Cardiac Care Crisis

Philips Future Health Index 2025: AI and Digital Tech Can Help Solve Cardiac Care Crisis

Optain Health Secures $26M to Advance AI-Powered Retinal Screening

Optain Health Secures $26M for AI-Powered Retinal Screening

Sutter Health and Epic Launch "Sutter Sync" to Optimize Remote Chronic Care

Sutter Health and Epic Launch “Sutter Sync” to Optimize Remote Chronic Care

Patient Square Capital Acquires Premier in $2.6B Deal

Pfizer Acquires Metsera for $4.9B, Expanding into Obesity and Cardiometabolic Market

Pfizer Acquires Metsera for $4.9B, Expanding into Obesity and Cardiometabolic Market

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |