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.