New Oracle Argus and Safety One Intake enhancements make it easier for
pharmacovigilance teams to increase efficiency and address global
regulatory compliance
AUSTIN,
Texas, July 10, 2024 /PRNewswire/ -- Oracle today
announced new capabilities in its AI-supported Oracle Argus and
Safety One Intake solutions to help
life science organizations meet evolving regulatory requirements
and the rising volume of adverse event case workloads. With new
enhancements designed to increase productivity, improve data
privacy, and enhance reporting, users can more efficiently address
dynamic, country-specific regulations and requirements, and speed
the reliability and transparency of safety case management from
clinical trials through post-marketing surveillance.
"Pharmacovigilance teams are seeking innovative solutions to
keep up with the unprecedented spike in drug safety cases," said
Seema Verma, executive vice
president and general manager of Oracle Health and Life Sciences.
"With the AI-powered enhancements to our life sciences safety
solutions, these teams can automate routine processes to submit
cases faster, meet global regulatory reporting obligations, and
stay compliant."
Built on scalable architecture backed by Oracle's decades of
expertise in safety, AI, and machine learning, the new capabilities
in Oracle's unified pharmacovigilance portfolio automate workflows
to optimize efficiency and regulatory adherence for pharmaceutical
and medical device companies, as well as clinical research
organizations (CROs). This includes requirements in Europe for data redaction and medical device
reporting obligations in the U.S. and Japan.
New Argus capabilities offer:
- Smart Duplicate Search: This smart algorithm helps users
find duplicate cases quickly. By using matching scores to reduce
the number of search iterations and enhance efficiency.
- Enhanced End-of-Study Unblinding: Users can unblind
cases in bulk faster through an intuitive new interface, increasing
operational productivity.
- Updates to Redaction of PII in Europe: Report mappings are updated in
accordance with EMA instructions for ICSRs transmitted to
non-European countries, ensuring compliance with the latest data
privacy regulations.
- eMDR Regulation Updates: Compliance with FDA CDRH
guidance updates to address regulatory requirements for medical
device reporting.
- CIOMS-I Report Updates: CIOMS-I report mappings are
updated to harmonize with E2B reports, improving report
comprehensiveness and accuracy.
Safety One Intake is an
AI-powered solution that automates the ingestion of safety source
documents into Argus, saving significant time by averting manual
data entry. New Safety One Intake
capabilities deliver:
- Automated Email Intake: Incoming individual case safety
reports automatically flow from safety email inboxes into Safety
One Intake, extracting relevant
content from the email subject and attachments. Acknowledgments are
automatically sent back to the email sender once a case is created,
which streamlines case intake procedures.
- CRO Support: With the ability to serve multiple
enterprises, or CRO clients, Safety One
Intake can be used by CROs to significantly increase their
workflow efficiency. This includes seamless maintenance of
configurations and intake processing activities for each
enterprise, helping ensure data segregation and the ability to
flexibly serve individual customer needs.
The new capabilities are available today. To learn more visit:
https://oracle.com/argus and
https://oracle.com/safety-one-intake
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 www.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.
Trademarks
Oracle, Java, MySQL and NetSuite are
registered trademarks of Oracle Corporation. NetSuite was the first
cloud company—ushering in the new era of cloud computing.
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SOURCE Oracle