Oracle has announced updates to its Argus and Safety One Intake solutions to help pharmacovigilance teams in life sciences organizations improve efficiency and address global regulatory compliance. The enhancements include new features to automate workflows, increase productivity, enhance data privacy, and streamline reporting. These improvements are designed to help users meet country-specific regulations and reporting requirements, ensuring the reliability and transparency of safety case management from clinical trials to post-market surveillance.
The enhancements include smart duplicate search capabilities in Argus, which allow users to quickly find duplicate cases with matching scores to improve efficiency. There are also updates to end-of-study disclosure processes and personally identifiable information wording in Europe to comply with the latest data privacy regulations. Additionally, there are updates to meet regulatory requirements in the US, Japan, and Europe for medical device reporting.
Safety One Intake, an AI-powered solution, automates the ingestion of safety documents into Argus, saving time by avoiding manual data entry. New features include automated email reception, where individual case safety reports flow from safety email inboxes into Safety One Intake, extracting relevant content from email subject and attachments. This streamlines case intake procedures and improves workflow efficiency, especially for clinical research organizations (CROs) serving multiple clients.
Oracle’s unified pharmacovigilance portfolio is built on a scalable architecture with decades of experience in security, AI, and machine learning. These new capabilities aim to help pharmaceutical and medical device companies, as well as CROs, optimize efficiency and regulatory compliance. By automating routine processes and streamlining reporting, teams can address the growing volume of adverse event case workloads and meet global reporting obligations.
For more information on the new enhancements to Oracle Argus and Safety One Intake, visit the Oracle website. Oracle Life Sciences is dedicated to supporting clinical development and leveraging real-world evidence to drive innovation in the life sciences industry, helping to improve patient outcomes. Oracle offers integrated suites of applications and secure infrastructure on the Oracle Cloud, serving professionals at large and emerging companies worldwide.
In summary, Oracle’s advancements in security case management for life sciences organizations aim to help pharmacovigilance teams increase efficiency, automate workflows, and address global regulatory requirements. The new features in Argus and Safety One Intake provide users with tools to streamline reporting, improve data privacy, and comply with country-specific regulations, ultimately enhancing the reliability and transparency of safety case management across the therapeutic development lifecycle.
Article Source
https://www.stocktitan.net/news/ORCL/oracle-advances-safety-case-management-for-life-science-2dyz9aslzf4k.html