Latest updates to Oracle Clinical One RTSM
cloud-based solution make it easier for sponsors and CROs to
configure, scale, and automate to support complex and global
clinical trial studies
BOSTON, May 1, 2024
/PRNewswire/ -- 6th Clinical Trial Supply Forum
-- 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:
https://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.
About Oracle Life Sciences
Oracle Life Sciences is a leader in cloud technology,
pharmaceutical research, and consulting, trusted globally by
professionals in both large and emerging companies engaged in
clinical research and pharmacovigilance, throughout the therapeutic
development lifecycle, including pre- and post-drug launch
activities. With more than 20 years of experience, Oracle Life
Sciences is committed to supporting clinical development and
leveraging real-world evidence to deliver innovation and accelerate
advancements – empowering the Life Sciences industry to improve
patient outcomes. Learn more at oracle.com/lifesciences
About Oracle
Oracle offers integrated suites of applications plus secure,
autonomous infrastructure in the Oracle Cloud. For more information
about Oracle (NYSE: ORCL), please visit us at www.oracle.com.
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SOURCE Oracle