Oracle has recently announced major updates to its Argus and Safety One Admission Solutions, incorporating AI technology to enhance its pharmacovigilance portfolio. These improvements aim to help life sciences organizations adapt to complex regulatory environments and handle a growing number of adverse events efficiently.
The new features focus on improving efficiency and compliance, making workflows smoother for pharmaceutical and medical device companies as well as clinical research organizations (CROs). Some of the key updates include:
– Enhanced data writing capabilities for Europe to comply with data privacy regulations and EMA instructions for internationally transmitted ICSRs.
– Compliance with the latest FDA CDRH guidelines for Medical Device Reports to meet reporting obligations in the US and Japan.
– Harmonization of CIOMS-I reporting mappings with E2B reporting to enhance reporting accuracy.
The Oracle Argus platform has benefited from significant updates, including a Smart Duplicate Search feature to identify duplicate cases easily, improved unblinding at the end of studies, and optimized reporting mappings for ease of use.
Safety One Intake, an AI-powered solution, automates the intake process of safety data from source documents into Argus. This eliminates the need for manual data entry, saving time and resources. The latest update includes automated email reception for security reports and CRO support to manage multiple companies effectively.
These new capabilities are now available for immediate use, providing life sciences organizations with the tools they need to navigate the evolving pharmacovigilance landscape more efficiently and with greater regulatory clarity.
Article Source
https://hitconsultant.net/2024/07/11/oracle-strengthens-pharmacovigilance-solutions-with-ai-powered-enhancements/
