Oracle Expands Its Worldwide RTSM Capabilities to Support Sponsors PR Newswire
Sponsors and CROs may now more easily configure, scale, and automate Oracle Clinical One RTSM, a cloud-based solution, to support intricate and international clinical research studies.
Boston, May 1, 2024 /PRNewswire/ The Sixth Clinical Trial Supply Forum Oracle today announced new features in Oracle Clinical One Randomization and Trial Supply Management (RTSM), which will assist sponsors and CROs in meeting the demands of intricate and international clinical trial studies. Users of Clinical One RTSM can now handle dynamic, nation-specific regulations and requirements and benefit from new features for use, access, and regionalization. This allows for increased trial speed, reliability, and transparency from start to finish.
Vice president of product and development for Oracle’s eClinical Applications Wissam Kazan stated, “RTSM solutions have historically been custom builds and code, which means that they take months to develop.” “We don’t want to require complex coding or programming so that sponsors can work quickly and focus on the important tasks, like organizing and carrying out the trial. With the help of Oracle’s extensive experience in data analytics, clinical trial management, and supply chain, our new RTSM enhancements offer a scalable and configurable architecture that cuts setup time from months to days.”
When it comes to managing regional data requirements in particular, traditional RTSM technology tends to painfully slow down overall efficiency when used to support trial supplies management. It is critical for sponsors and CROs to embrace patient-centered, cutting-edge, and international technologies in light of the growing popularity of decentralized clinical trials (DCT) and the pressing need to involve wide populations worldwide.
The Oracle platform has undergone new improvements that enable sponsors and CROs to more quickly and flexibly customize intricate studies to suit their worldwide needs. With the help of significant updates in the latest release, sponsors and CROs can:
The randomization list can be automatically created by users based on the study design. This allows for on-demand regeneration and regulatory reporting to support production.
To help meet regional requirements easily and without a change order, modify the Do Not Dispense (DND) Exceptions by enabling changes in the distribution settings.
Customized forms for the processes of reconciliation and trial supply return are called design reconciliation forms.
Allow Future Date (Rapid Build): This feature allows you to quickly define date fields in your designs. In order to notify end users when they have entered a future date, custom rules are not required. Now, it only takes a button click.
Maximizing the integrated query management system, operational site, and subject data are now accessible for writing rules. Write Rules Using Operational Data. It also makes it simpler to lessen the load on trial and sponsor users, which helps to boost trial efficiency.
With flexibility and interoperability in mind, Oracle RTSM offers a wide range of features. Because it makes managing complicated procedures easier and can adapt to changing national and regulatory requirements, the platform speeds up clinical trials. With no code builds or downtime amendments required, its configurable architecture allows users to quickly and easily design trials.
Innovative built-in and improved reporting and analytics for cross-study analytics, real-time data, and personalized dashboards and visualizations are also features of Oracle RTSM. With its zero-tolerance and security-first architecture, the platform can be tailored to individual patient needs by integrating with an expanding partner ecosystem of DCT capabilities.
According to Joel Harris, study sponsor WallabyPhenox, who used Oracle RTSM for the pRESET Thrombectomy device trial, which recently received FDA clearance for the U.S. market, “using Oracle RTSM, our U.S. clinical trial went smoothly, and the solution was quickly configured to handle our uniquely complex randomization and stratification requirements.” We couldn’t have completed the project by the deadline without Oracle, and we are happy with the outcome.