Solution Combines Trial Management, Mobile Monitoring, and Real-time Analytics to Support Monitoring Strategies including Risk-Based Monitoring Best Practices
Life sciences and clinical research organizations (CROs) are looking to improve project oversight, make smarter trial decisions and gain efficiencies across clinical operations, while supporting patient safety, data integrity and compliance. The Oracle Clinical Monitoring Cloud helps companies achieve these goals by integrating three key solutions in the Oracle Health Sciences Cloud: Oracle Siebel Clinical Trial Management System Cloud Service (CTMS) for advanced trial management capabilities, native mobile app Oracle Health Sciences Mobile CRA for mobile monitoring, and Oracle Health Sciences Clinical Development Analytics (CDA) for comprehensive, real-time visibility to clinical and operational data.
- Oracle Health Sciences today announced the Oracle Clinical Monitoring Cloud, a flexible and scalable solution integrating clinical trial management, comprehensive analytics and mobile monitoring in the Oracle Health Sciences Cloud.
- Combining these three capabilities into one solution helps organizations enhance patient safety and reduce trial cost and risk by supporting the fast, accurate development and implementation of an organization’s own monitoring strategies and processes.
- The Oracle Clinical Monitoring Cloud is integrated with Oracle Health Sciences Inform Cloud Service, providing automated data flow, making it easier to monitor and analyze clinical data in real-time to help ensure data timeliness, quality, and compliance with the protocol.
- The solution facilitates the development and implementation of virtually any monitoring strategy – whether centralized monitoring, targeted monitoring, reduced monitoring, or risk-based monitoring in accordance with Food and Drug Administration (FDA), European Medicines Agency (EMA) and TransCelerate BioPharma guidance and best practices.
- Comprehensive trial management capabilities helps organizations quickly identify underperforming trials and problematic data, make fast and accurate decisions with real-time enrollment and site performance metrics in a centralized trial management database, and provide effective management of sites and subjects to help increase efficiency and productivity.
- The solution leverages the transformative potential of native clinical mobile applications to enable efficient and proactive monitoring and productive site visits, maximizing the utilization, efficiency and productivity of monitoring resources.
- The comprehensive analytics capabilities include pre-built and configurable role-based dashboards and key performance indicators that help measure and drive improved monitoring and project oversight, and streamline and optimize operations across all phases of clinical trials.
- As a cloud-based offering, organizations can achieve rapid time to value, high availability and lower total cost of ownership through reduced and predictable infrastructure, compliance and IT operating costs.
- “By combining three critical trial management and monitoring capabilities into one integrated solution, our customers can gain significant clinical operating efficiencies through real-time visibility into clinical trial progress. This scalable and integrated cloud platform automates trial planning, start-up, clinical operations, data management and site reimbursement processes, while giving organizations the flexibility to implement their trial monitoring strategies to enhance patient safety while reducing trial cost and risk,” said Mukhtar Ahmed, global vice president of product strategy, Oracle Health Sciences.