By Michael McCann | Global Vice President Sales, Alliances and Channels
Safety is the cornerstone of clinical trials but capturing and reporting adverse events is a challenge.
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. 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.”
—Nathan Thompson, chief information officer, UBC
According to research from Ernst & Young, 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.
Register now for The Safety Innovation Summit Europe 2023, which is open to all safety professionals involved in pharmacovigilance.
Learn more about Oracle Argus Cloud Service
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Michael McCann
Global Vice President Sales, Alliances and Channels
Michael McCann has over 30 years of experience in enterprise technology across life sciences domains including drug discovery, clinical development, regulatory and commercial. He has been the global sales leader for Oracle's Health Sciences group since its October 2020. Prior to that he led the Americas Health Sciences sales organization since the business unit’s inception in 2008.
As the global sales leader, Michael is responsible for the growth of clinical development and pharmacovigilance solutions relied upon by biotech, pharma, medical device, and CRO customers. Prior to Oracle he was part of the life sciences group at Siebel Systems, VP of Sales at Active Strategy, VP of Sales at EMAX Solutions, Sales VP at Computer Associates, and software engineer at Unisys Corporation.
Michael McCann holds a Bachelor of Arts degree in Computer Science and Finance from LaSalle University and an MBA in International Business from the LeBow College of Business at Drexel University.
