What You Should Know:
– Oracle has introduced significant advancements to its Electronic Data Capture (EDC) solution, Oracle Clinical One Data Collection. These new capabilities are designed to simplify clinical workflows and eliminate data friction across systems, which helps accelerate research, improve safety reporting, and bring new therapies to market faster.
– The updates, developed in collaboration with pharmaceutical industry leaders and Oracle’s CRO Growth Network collaborators, reflect Oracle’s commitment to delivering AI-driven, interoperable solutions that enhance automation and streamline data connectivity.
Comprehensive EHR Integration and Data Management
The new EDC enhancements enable researchers to use the AI-enabled Oracle Clinical Connector to securely transfer data between Oracle Health and other EHRs and Oracle Clinical One Data Collection. This integration removes manual busywork by enabling direct, EHR data transfers that can help improve accuracy and speed research.
The latest release also increases document management capabilities for clinical sites. This allows site staff to upload all file formats at the subject level, such as a subject’s scanned lab results, directly into the platform using a mobile device. This helps teams keep documentation centralized and supports a more complete view of the subject.
Streamlining Safety Reporting and Compliance
Reporting serious adverse events (SAE) often requires duplicative effort across disconnected systems, which can slow research and risks quality. Clinical One Data Collection now offers integrated safety capabilities across the workflow for faster and more accurate adverse event management.
The safety integration uses the ICH E2B(R3) standard, which enables sites to more quickly and seamlessly meet their regulatory compliance obligations to immediately report the occurrence of SAEs to the trial sponsor. The integration is fully interoperable with Oracle Safety One Argus and other safety solutions, giving customers choice and flexibility.
“Our EDC enhancements underscore Oracle’s commitment to delivering AI-driven capabilities and aligning clinical research and clinical care by creating a more open healthcare ecosystem that fuels medical breakthroughs for the patients who desperately need them,” said Seema Verma, executive vice president and general manager of Oracle Health and Life Sciences.
Availability
The new features and enhancements within Oracle Clinical One Data Collection are available to customers globally as part of their standard clinical update process.
