Oracle today announced new capabilities in its AI-supported Oracle Argus and Safety One Intake solutions to help life science organizations meet evolving regulatory requirements and the rising volume of adverse event case workloads. With new enhancements designed to increase productivity, improve data privacy, and enhance reporting, users can more efficiently address dynamic, country-specific regulations and requirements, and speed the reliability and transparency of safety case management from clinical trials through post-marketing surveillance.

“Pharmacovigilance teams are seeking innovative solutions to keep up with the unprecedented spike in drug safety cases,” said Seema Verma, executive vice president and general manager of Oracle Health and Life Sciences. “With the AI-powered enhancements to our life sciences safety solutions, these teams can automate routine processes to submit cases faster, meet global regulatory reporting obligations, and stay compliant.”

Built on scalable architecture backed by Oracle’s decades of expertise in safety, AI, and machine learning, the new capabilities in Oracle’s unified pharmacovigilance portfolio automate workflows to optimize efficiency and regulatory adherence for pharmaceutical and medical device companies, as well as clinical research organizations (CROs). This includes requirements in Europe for data redaction and medical device reporting obligations in the U.S. and Japan.

New Argus capabilities offer:

• Smart Duplicate Search: This smart algorithm helps users find duplicate cases quickly. By using matching scores to reduce the number of search iterations and enhance efficiency.
• Enhanced End-of-Study Unblinding: Users can unblind cases in bulk faster through an intuitive new interface, increasing operational productivity.
• Updates to Redaction of PII in Europe: Report mappings are updated in accordance with EMA instructions for ICSRs transmitted to non-European countries, ensuring compliance with the latest data privacy regulations.
• eMDR Regulation Updates: Compliance with FDA CDRH guidance updates to address regulatory requirements for medical device reporting.
• CIOMS-I Report Updates: CIOMS-I report mappings are updated to harmonize with E2B reports, improving report comprehensiveness and accuracy.

Safety One Intake is an AI-powered solution that automates the ingestion of safety source documents into Argus, saving significant time by averting manual data entry. New Safety One Intake capabilities deliver:

• Automated Email Intake: Incoming individual case safety reports automatically flow from safety email inboxes into Safety One Intake, extracting relevant content from the email subject and attachments. Acknowledgments are automatically sent back to the email sender once a case is created, which streamlines case intake procedures.
• CRO Support: With the ability to serve multiple enterprises, or CRO clients, Safety One Intake can be used by CROs to significantly increase their workflow efficiency. This includes seamless maintenance of configurations and intake processing activities for each enterprise, helping ensure data segregation and the ability to flexibly serve individual customer needs.

The new capabilities are available today. To learn more visit: https://oracle.com/argus and https://oracle.com/safety-one-intake