1 About Oracle Argus Interchange
Oracle Argus Interchange is an electronic submission and exchange module that enables the transmission of required ICH:E2B reporting functionality as well as the exchange of vital drug safety information with regulators and partners worldwide. Cases are reported instantly and accurately using standardized, worldwide reporting and transmission processes.
A color-coded graphical display provides peace of mind by delivering real-time insight into transmission status. Further, Oracle Argus Interchange is seamlessly integrated with Oracle Argus Safety, facilitating import, export, and transmission of cases. In addition, it supports immediate case triage upon electronic intake of data.
Oracle Argus Interchange provides the critical link to connect the pre-clinical and post-marketing safety information domains. This is the crucial component enabling pharma companies to communicate between their e-clinical and safety systems, delivering immediate return on investment gains. Oracle Argus Interchange will allow any standards-based systems (ICH:E2B to CDISC:ODM) to instantly exchange adverse events data. It thereby eliminates costly data entry redundancy and any possibility for introduction of errors.
Note:
The term E2B that is used in this document refers to E2B (R2), E2B (R3), and eVAERS reports.
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