KING OF PRUSSIA, PA, 29 October 2024 — United BioSource LLC (UBC), a leading provider of evidence development solutions for the biopharmaceutical industry, today announced a partnership with Osmind Inc., the leading psychiatric treatment and research platform, to support clinicians and drug developers in delivering innovative treatments to patients with psychiatric conditions. This collaboration brings together UBC’s industry-leading expertise in Risk Evaluation and Mitigation Strategies (REMS) with Osmind’s purpose-built mental health electronic health record (EHR) platform to create a first-of-its-kind EHR integration for REMS based on the FDA-supported HL7® CodeX FHIR® Accelerator Community and REMS Integration Use Case.
A number of key stakeholders, including prescribers, nurses, pharmacists, REMS administrators, and drug manufacturers, play a role in fulfilling the REMS requirements. However, the lack of integration of REMS programs into prescriber workflows, and the absence of a standardized way to share data between REMS stakeholders, leads to additional administrative burden, reduces compliance, and drives up cost — ultimately delaying or reducing patient access to REMS drugs.
“We’re extremely happy to build on our continued commitment to, and investment in, the HL7 standards for the integration of REMS into prescriber workflows,” said Nate Thompson, Chief Information Officer at UBC. “This is an important initial step for standards adoption and for actualizing the promise of reduced burden, improved REMS compliance, and superior data quality.”
“As the industry leader in REMS services and technology, we look forward to working with Osmind to shape the future of psychiatric drug development by providing seamless access to real-world data and insights, thereby accelerating the delivery of novel therapies for patients,” said Natalie O’Donnell, Senior Vice President, Head of Safety and Risk Management at UBC.
The partnership is key to advancing:
- Better patient care, by allowing prescribers using Osmind to remain in their existing workflow when submitting REMS-required documentation, thereby minimizing the need for additional data entry. This allows prescribers to focus on patient care instead of navigating to an external REMS website.
- Reduced operational overhead for prescribers, dispensing staff, and REMS administrators, by eliminating the need for inbound faxes, which, in turn, reduces the amount of manual processing by the administrator.
- Improved data quality by integrating information directly from the prescriber’s EHR into the REMS database in a secure, private system-to-system channel.
- Enhanced REMS process efficiency, by speeding up the notification of safety events and simplifying REMS monitoring through the elimination of manual processing.
- Increased REMS compliance for the prescriber’s office, the REMS, and the sponsor.
This initiative sets the stage for broader EHR-REMS integration in the future, including patient status forms, enrollment forms, diagnostic testing results, and more.
“Innovation in mental health care is advancing rapidly. But a significant gap remains between research and real-world patient care,” said Jimmy Qian, Co-founder, and President at Osmind. “Clinicians often struggle to keep pace with new treatments while managing the administrative burden of delivering them. Partnering with UBC, alongside other technology leaders, allows us to streamline these processes, accelerate access to breakthrough therapies, and enable clinicians to focus more on patients in need.”
About UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate 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. For additional information, visit www.ubc.com.
About Osmind
Osmind Inc. is a public benefit corporation advancing psychiatry through technology and real-world evidence to bring innovative mental health treatments to patients in need. Our psychiatry-tailored software, used by mental health practices across the U.S., captures deep clinical data to help clinicians and life sciences improve patient outcomes. Leveraging real-world data, an engaged clinic network, and direct patient relationships, Osmind supports life sciences across translational research, clinical development, medical affairs, HEOR, pharmacovigilance, and commercial applications. Learn more at www.osmind.org.
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