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Out-of-the-Box Integration Automates Adverse Event Data Transfer Using E2B Standards to Increase Efficiency and Improve Safety Data Quality
To help clinical trial sponsors and contract research organizations (CROs) more cost-effectively and efficiently capture and manage information on adverse events, Oracle has integrated Oracle Health SciencesInForm and Oracle Argus Safety. By automating the transfer of serious adverse event (SAE) and related information from the Oracle Health Sciences InForm clinical data management system to the Oracle Argus Safety system, the integration can virtually eliminate the time, and significantly reduce the costs and potential for error associated with reformatting and rekeying data. The out-of-the-box integration, which supports both drug and medical device trials, provides a proven, robust, and configurable integration between Oracle Health Sciences InForm and Oracle Argus Safety that speeds time to deployment, virtually eliminates custom development costs, and allows managers to select how often SAE information and updates are delivered to the safety system, as well as whether the information is transmitted automatically or based on user action.
Adverse event information from Oracle Health Sciences InForm is now available to safety teams within minutes as opposed to hours or days, allowing sponsors and CROs to assess potential SAEs faster and facilitate compliance with regulatory reporting requirements. Organizations can also save valuable time at the end of an electronic data capture (EDC) trial by avoiding time-consuming reconciliations between data across the clinical data management and safety systems. This closed-loop solution is designed to improve cross-organizational communication and provides up-to-date information by returning Oracle Argus Safety case numbers and status notifications back to Oracle Health Sciences InForm.
“Out-of-the-box integration between Oracle Health Sciences InForm and Oracle Argus Safety helps trial sponsors and CROs to respond faster to potential SAEs while reducing the costs and potential for error involved in rekeying information. It also ensures consistent information between the clinical data management and safety systems, which expedites data validation at the end of a trial, ultimately accelerating time to regulatory submission,” said Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences.