United BioSource, LLC (UBC), the leading provider of evidence-based research for the biopharma industry, has migrated its safety functions from on-premises to Oracle Argus Cloud Service, a trusted safety case management solution. UBC specializes in generating real-world evidence of product effectiveness, safety, and value that enable emerging and leading pharmaceutical companies to make medicine and specialty therapies safer and more accessible.
“UBC is committed to helping our clients make informed decisions and optimize the care given to patients using their therapies,” said Nathan Thompson, chief information officer, UBC. “Oracle Argus Cloud Service provides a powerful innovative, agile, and secure technology that can enable us to better manage all safety aspects of even our most complex trials. Using a cloud-based safety solution reduces operational complexities and helps refocus our valuable resources on other parts of the business. We value our ongoing collaboration with Oracle for the development of its next-generation safety technology.”
According to research from Ernst & Young1, large pharmaceutical companies contend with an average of 700,000 adverse event (AE) cases each year. With caseloads and regulations continuously changing, efficient case management and compliance are mission-critical for any organization.
Running on the security and performance of Oracle Cloud Infrastructure, Oracle Argus Cloud Service will provide UBC with state-of-the-art safety case processing for its clinical trials as well as post-marketing programs. With it, UBC can optimize its workflow by automating routine steps, reducing manual work, and cutting processing times. It also enables UBC to address its global compliance goals with aggregated and expedited reporting.
“We are committed to delivering next-generation safety solutions that address the very complex challenges around drug safety and post-market surveillance,” said Seema Verma, senior vice president and general manager, Oracle Life Sciences. “Using Oracle Argus Cloud Service can help position UBC to market its unique capabilities and attract additional business. Because we handle the maintenance in the cloud, we remove some of the risk, time, and challenges that maintaining software on premises can pose so UBC can remain focused on what matters most working to make medicine and specialty therapies safer and more accessible.”
Oracle Argus Cloud Service is the central location for documenting all data about adverse events including source documents, assessments, and regulatory reports, and it’s the single source of truth for downstream aggregate analytics and signal detection. Oracle Argus Cloud Service can provide UBC with safety case management features and benefits including:
• Capabilities to help address compliance with global regulations and standards;
• Lower cost and complexity through SaaS deployment;
• Efficient case processing via automation and ease-of-use;
• Powerful, extensible, and user-friendly analytics and reports;
• Lower total cost of ownership.
The Safety Innovation Summit Europe 2023 on Oct. 2-3 in Utrecht, Netherlands will outline Oracle’s continuing journey of advancing pharmacovigilance through innovation.
1. Ernst & Young,“How robotics is reshaping the biopharma value chain”
About United BioSource, LLC (UBC)
United BioSource, LLC (ubc.com) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstration safety, efficacy, and value under real-world conditions. Underpinned by our scientific expertise, data and analytics, and innovative technologies, we offer our customers flexible solutions generating the relevant real-world data necessary to make more informed decisions earlier, meet stakeholder requirements, and, ultimately, drive better patient outcomes.
About Oracle Life Sciences
Oracle Life Sciences (oracle.com/lifesciences) 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’ experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to help deliver innovation and accelerate advancements empowering the Life Sciences industry to help improve patient outcomes.
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