Helping sponsors and CROs meet the challenges of complex and global clinical trial studies, Oracle today announced new capabilities in Oracle Clinical One Randomization and Trial Supply Management (RTSM). With new enhancements for use, access, and regionalization, Clinical One RTSM users can address dynamic, country-specific regulations and requirements, and gain speed, reliability, and transparency of trials from commencement to closeout.

“Historically, RTSM solutions have been custom builds and code, which means that they take months to develop,” said Wissam Kazan, vice president of product and development for eClinical Applications, Oracle. “Our goal is to empower sponsors to move fast and focus on the core things that matter - designing and running the trial without complex programming and coding. Our new RTSM enhancements leverage the decades of expertise Oracle has in supply chain, data analytics, and clinical trial management to deliver a configurable, scalable architecture to reduce set-up time from months to days.”

Traditional RTSM technology used to support trial supplies management often puts a painful lag on overall efficiency, especially when managing regional data requirements. With the rise of decentralized clinical trials (DCT) and the urgent need to include diverse global populations, it is crucial for sponsors and CROs to adopt patient-centered, modern, and global technologies.

The new enhancements to the Oracle platform empower sponsors and CROs to be able to more easily tailor complex studies that can meet their global needs with speed and flexibility. Key updates in the new release provide CROs and sponsors the ability to:

• Automate Creation of Randomization List: Users can generate a randomization list based on study design to support production through regulatory reporting with on-demand regeneration.
• Modify Do Not Dispense (DND) Exceptions: Enable modifications in the distribution settings to help meet regional requirements easily and without a change order.
• Design Reconciliation Form: Customized forms for Reconciliation and Trial Supplies Return processes.
• Disallow Future Date (Rapid Build): Quick design feature for defining date fields. There is no need to write custom rules to alert end users when they have entered a future date. It is now a click of a button.
• Create Rules with Operational Data: Maximizing the built-in query management system, operational site and subject data is now exposed to write rules. This helps to increase trial efficiency and makes it easier to reduce the burden on trial and sponsor users.

Oracle RTSM offers comprehensive capabilities, engineered for interoperability, and flexibility. The platform expedites clinical trials by simplifying the management of complex processes and the ability to keep pace with changing regulatory and country standards. Its configurable architecture enables customers to design trials easily with rapid setup and deployment and no code builds or downtime amendments. Oracle RTSM also has innovative built-in and enhanced reporting and analytics for real-time, cross-study analytics, and customized dashboards and visualizations. The platform has a security-first and zero-tolerance infrastructure that integrates with a growing partner ecosystem of DCT capabilities, providing flexibility and optionality to meet patient needs.

“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,” said Joel Harris, study sponsor, WallabyPhenox, who used the RTSM solution for the pRESET Thrombectomy device trial, which has recently received FDA clearance for the U.S. market. “Without Oracle, we would not have met our timelines, and we’re delighted with the results.”

To learn more about Oracle Clinical One Randomization and Trial Supply Management (RTSM) visit: www.oracle.com/life-sciences/clinical-research/clinical-one-randomization-supplies-management/

Don’t miss Oracle Life Sciences at the 6th Clinical Trial Supply Forum May 2-3 in Boston.