AUSTIN, Texas, July 10, 2024 — Oracle has introduced advanced features in its AI-powered Oracle Argus and Safety One Intake solutions to support life science organizations in managing regulatory requirements and increased adverse event case volumes. These new enhancements are designed to boost efficiency, enhance data privacy, and improve reporting capabilities, enabling users to navigate country-specific regulations more effectively and enhance the reliability and transparency of safety case management from clinical trials to post-marketing surveillance.
“Pharmacovigilance teams are facing a significant rise in drug safety cases,” said Seema Verma, Executive Vice President and General Manager of Oracle Health and Life Sciences. “Our AI-driven enhancements allow these teams to automate routine processes, expedite case submissions, meet global regulatory requirements, and maintain compliance.”
Oracle’s new capabilities in its pharmacovigilance suite, built on a scalable architecture with decades of safety, AI, and machine learning expertise, optimize workflows for pharmaceutical and medical device companies and clinical research organizations (CROs). This includes compliance with European data redaction requirements and U.S. and Japanese medical device reporting obligations.
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Key Argus Enhancements:
- Smart Duplicate Search: A smart algorithm reduces search iterations by using matching scores, making it easier to find duplicate cases.
- Enhanced End-of-Study Unblinding: An intuitive new interface allows users to unblind cases in bulk, improving operational productivity.
- PII Redaction Updates for Europe: Report mappings are updated to comply with EMA instructions for ICSRs sent to non-European countries.
- eMDR Regulation Updates: Aligns with FDA CDRH guidance for medical device reporting.
- CIOMS-I Report Updates: Harmonizes CIOMS-I report mappings with E2B reports for improved accuracy and comprehensiveness.
Safety One Intake Enhancements:
- Automated Email Intake: Automatically processes incoming safety reports from email inboxes, extracts relevant content, and sends acknowledgments, streamlining case intake procedures.
- CRO Support: Enhances workflow efficiency for CROs by maintaining configurations and processing activities for multiple enterprises, ensuring data segregation and flexible customer service.
These new capabilities are now available. For more information, visit Oracle Argus and Oracle Safety One Intake.
About Oracle Life Sciences: Oracle Life Sciences, a global leader in cloud technology and pharmaceutical research, supports clinical development and leverages real-world evidence to drive innovation and advancements in the therapeutic development lifecycle. With over 20 years of experience, Oracle Life Sciences is dedicated to improving patient outcomes. Learn more at Oracle Life Sciences.
About Oracle: Oracle provides integrated application suites and secure, autonomous infrastructure through Oracle Cloud. For more information, visit Oracle.