Key Highlights:
– Oracle has made major improvements to its Electronic Data Capture (EDC) platform, Oracle Clinical One Data Collection. These enhancements aim to streamline clinical workflows and reduce data barriers between systems, speeding up research, improving safety reporting, and accelerating the delivery of new therapies.
– Developed in partnership with pharmaceutical industry leaders and Oracle’s CRO Growth Network collaborators, these updates demonstrate Oracle’s dedication to providing AI-powered, interoperable solutions that boost automation and enhance data integration.
Seamless EHR Integration and Enhanced Data Management
The new enhancements to the EDC empower researchers to securely transfer data between Oracle Health, other EHR systems, and Oracle Clinical One Data Collection using the AI-powered Oracle Clinical Connector. This integration eliminates manual tasks by enabling direct EHR data transfers, improving data accuracy and accelerating research.
Additionally, the latest update expands document management capabilities for clinical sites, allowing staff to upload various file formats—such as scanned lab results—at the subject level directly via mobile devices. This centralizes documentation and provides a more comprehensive view of each subject.
Enhancing Safety Reporting and Regulatory Compliance
Reporting serious adverse events (SAEs) often involves repetitive tasks across disconnected systems, which can delay research and compromise data quality. Oracle Clinical One Data Collection now features integrated safety capabilities throughout the workflow, enabling faster and more precise management of adverse events.
This safety integration leverages the ICH E2B(R3) standard, allowing clinical sites to efficiently and promptly fulfill regulatory requirements by reporting SAEs directly to trial sponsors. The solution is fully compatible with Oracle Safety One Argus and other safety platforms, providing customers with greater flexibility and choice.
“Our enhancements to the EDC highlight Oracle’s dedication to AI-powered innovations and bridging clinical research with patient care through a more open healthcare ecosystem that accelerates medical breakthroughs for patients in need,” said Seema Verma, Executive Vice President and General Manager of Oracle Health and Life Sciences.
Availability
The new features and enhancements in Oracle Clinical One Data Collection are now available worldwide to customers through the standard clinical update process.
