The new PV reporting platform will propel UBC’s delivery of high-impact, insight-driven drug safety services by providing a more comprehensive and sophisticated aggregate reporting solution. 

“This isn’t a reporting tool upgrade — it’s a foundational shift,” said Geraldine Aubes, Executive Director and Global Head of Pharmacovigilance at UBC. “We are building the future of PV, where every function, from case intake to analytics, is integrated, scalable, and intelligent.” 

Building on the reliability of UBC’s existing PV ecosystem and complementing its current, industry-leading safety database, the new PV reporting platform brings further time efficiencies and reduces regulatory risk. Its capabilities include: 

• Enhanced report output templates, drawing on a library of UBC Gold Standard reporting templates, such as cumulative summary tabulations, interval line listings, and blinded SUSAR listings — all compliant with aggregate regulatory reporting requirements. 

• Improved accessibility and transparency, as an advanced self-service, user-friendly tool with real-time generation of graphs and visualizations and the ability to schedule recurring reports. 

• Faster ad-hoc reporting, enabled by the ability to create custom reports on the fly with less IT support, as well as respond quickly and comprehensively to regulatory or internal queries. 

Reducing the need for manual oversight, the new platform enables PV professionals to spend more time on risk evaluation, regulatory strategy, and patient-centric insights. This initiative sets the stage for additional safety reporting enhancements in the future. 

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 RxLogix Corporation 

RxLogix is a global pharmacovigilance solutions company specializing in innovative software and expert consulting services. Our talented team of business and technology innovators works with Pharmacovigilance and Risk Management Professionals to help increase the compliance, productivity, and quality for the entire Drug Safety value chain. We are business transformers, digital thinkers, tech Innovators, technology revolutionists, business mavericks, driven and open-minded individuals. At RxLogix, our goal is to make the most innovative industry standard software for the life sciences domain. For additional information, visit www.rxlogix.com. 

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“Establishing a technically advanced, audit-ready PV operation that prioritizes quality and compliance is essential for the success of all life science companies,” remarked Geraldine Aubes, Executive Director, Global Head of UBC Pharmacovigilance. “This distinction verifies UBC’s commitment to maintain patient safety and ensure high regulatory compliance throughout the drug development and commercialization process.”

The success of a PV operation is essential for all life science companies, and is shaped by evolving regulatory requirements, rising case volumes, complex safety profiles, and the need for global compliance. UBC offers a flexible, collaborative approach to delivering tailored PV programs that support regulatory obligations, ensure global safety compliance, and protect patient wellbeing. UBC’s comprehensive solutions include strategic partnerships, customized programs, global regulatory expertise, end-to-end PV services, expert case processing and reporting, in-depth literature reviews, and high-quality safety writing.

The Everest Group PEAK Matrix is a proprietary framework used to evaluate market success and technology services based on performance, experience, ability, and knowledge. Service providers are comparatively assessed on their market impact and delivery capabilities.

In this year’s assessment, Everest Group evaluated 29 leading PV operations providers featured on the PV Operations PEAK Matrix. Each provider profile presents a holistic view of service focus, solution offerings, and domain-specific investments. The analysis is based on Everest Group’s annual RFI (request for information) process for calendar year 2024, along with PV provider, client reference checks, and ongoing market research.

“Pharmacovigilance isn’t just about compliance — it’s about safeguarding lives with precision, expertise, and innovation. This recognition by Everest Group is a testament to our pursuit of excellence,” said Natalie O’Donnell​, Senior Vice President and Head of Safety and Risk Management at UBC. “We’re not just keeping pace with evolving safety demands — we’re helping our clients stay ahead of them.”

To read about Everest Group’s Pre-approval Pharmacovigilance Operations PEAK Matrix Assessment 2025, visit here. To read about UBC’s pharmacovigilance solutions, visit here.

Media Inquiries

Maggie Williard
Account Executive, HDMZ
maggie.williard@hdmz.com
(312) 506-5239

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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.”

MEDIA INQUIRIES

Mohana Ray

Scientific Director, HDMZ

mohana.ray@hdmz.com

312-506-5210

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SitePlus provides a next-generation research model that can be initiated from initial study design and launch or added alongside any ongoing Phase II – IV study nationwide. SitePlus offers a central site model which extends the reach of sites and widens the addressable patient population. The solution leverages a centralized technology platform to accelerate patient recruitment, facilitate home health engagement, securely capture data, and enable superior patient retention.

SitePlus combines UBC’s industry leading late-stage research solutions with Thread’s technology to empower central site study designs focused on patients while improving the research experience for all participating sites. It further enables biopharma sponsors to contract with UBC as a central research center inclusive of investigator and study coordinating center concierge support services. SitePlus connects UBC’s central principal investigator, home health, and patient coordinating center expertise with Thread’s unified technology platform and consulting services for data capture, virtual visits, and optimized patient engagement.

“Study designs that rely exclusively on brick-and-mortar site models can benefit from the enhancements SitePlus offers to help meet their patient enrollment and retention goals,” said Bekki Bracken Brown, President & Chief Executive Officer, UBC. “Studies leveraging a hybrid approach have seen success in reaching a more representative patient population, faster, and maintaining patient engagement. The Thread technology platform supports our central site offering by enabling a more flexible approach to patient recruitment and engagement and strengthens the return on evidence generation for our customers. “

UBC and Thread’s enterprise collaboration continues to enrich UBC’s modernized study designs and eCOA solutions that enable patient-centered research studies to be conducted in the clinic, in the home, and on-the-go.

“Based on strong early results with SitePlus for our joint customers, we are excited to expand its features to offer solutions in both interventional and post-approval research studies,” said Thread Co-Founder and CEO John Reites. “We appreciate UBC’s continued partnership and the feedback from our biopharma customers to add more value to this important innovative offering’s market growth.”

Learn more about SitePlus at www.AddSitePlus.com

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.

MEDIA INQUIRIES

Amber Frasketi

Head of Marketing & Strategic Communications

UBC

Phone: +1 215.588.8423

Email: amber.frasketi@ubc.com

About Thread   

Thread’s® purpose is to leverage its decentralized research platform to enable studies for everyone, everywhere. The company’s uniquely combined clinical research technology and consulting services help life science organizations to design, operate, and scale next-generation research studies and electronic clinical outcome assessments (eCOA) programs for participants, sites, and study teams. Through its comprehensive platform and scientific expertise, Thread empowers studies to be accessible, efficient, and centered on the patient. Backed by health care investors Water Street Healthcare Partners and JLL Partners, Thread is recognized as a leader by Everest Group’s Decentralized Clinical Trial Product PEAK Matrix® Assessment 2021/2022 and positioned in the Leader’s Category of the 2022 IDC MarketScape for R&D Decentralized Clinical Trial Technology Solutions Vendor Assessment 2022. Visit Threadresearch.com to learn more.    

Media Contact:   

Les Yates 

Thread  

Media@Threadresearch.com  

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The study UBC is recognized for includes tokenizing the data of pragmatic trial participants and linkages to 16 real-world data sources. The goal is to inform understanding of the patient journey before and after enrollment, as well as assess medication effectiveness and safety risks against usual care.

As a leader in modernized study designs that generate critical real-world evidence of safety and effectiveness, UBC is proud to be recognized for our work on this study design and execution. If you would like to learn more about how UBC incorporates the right mix of tools and techniques to efficiently and effectively achieve your study aims, get in touch with us here.

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In March 2022, UBC and Seqster launched an ongoing, longitudinal, real-world treatment outcomes study in the US of patients receiving treatment for a rare type of benign tumor in the joints that is disabling physically, mentally, and socially. The study objectives are to collect longitudinal patient-reported outcomes and clinical data on treatment patterns and clinical outcomes. Given that the patient population is a rare disease population receiving a medical therapy that is only accessible via managed distribution, site recruitment and site-based patient enrollment were challenging, and the research was impractical to conduct via sites exclusively.

UBC and Seqster partnered to amend the study into a direct-to-patient approach for enrollment using a secure, digital platform to access patients’ medical records. Once registered, patients are provided access to their patient portals through the SEQSTER solution to bring their electronic medical records (EMR) into the dashboard for the research team to perform data abstraction. This allows any eligible patients to be able to participate in the research without the need to enroll the patient’s treating physician as a site in the study. In this model, UBC can recruit 100% of the eligible patient population regardless of their geography or proximity to a site.

In this rare disease population, this methodology was fundamentally vital in enabling the research team to enroll a total number of patients that would generate meaningful analysis. Furthermore, this model reduces the burden on the healthcare provider for performing data abstraction as this activity is performed by a central team. The synergy between UBC and Seqster in putting Patients First created a natural fit for this partnership and allowed this research, which would not have been feasible in a traditional, site-based model, to succeed.

UBC is proud of the early results of this partnership and the recognition it has achieved with the Citeline Awards. To learn more about UBC’s lifecycle solutions in rare disease, click here. To dive into how we partner with biopharma to generate comprehensive evidence of product safety and effectiveness.

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With a focus on enabling healthcare interoperability through FHIR, Connectathon participants meet several times a year to work alongside vendors, peers, healthcare providers, and administrators, to rapidly learn to implement the standard and validate their conformance to the specification and mature implementation guides. 

During Connectathon, UBC successfully implemented the Risk Evaluation and Mitigation Strategies (REMS) administration software, including the CDS Hooks Services and SMART App Launch as described in scenario 1 and 2 against an EHR test system. 

“Connectathon participation is a critical component to advancing interoperability, and we are thankful for UBC’s efforts, as we were able to experience the workflows first-hand.  The process allows us to fine-tune the standards so we can efficiently integrate REMS into workflows, share data across stakeholders, and reduce burden on staff and patients,” said Kelee Petzelt, REMS Use Case Coordinator, Point of Care Partners/CodeX.

“The business value derived from this technology is best understood from the workflow of a prescriber” said Natalie O’Donnell, SVP, Head of Safety & Risk Management, UBC. The technology enables the prescriber, within their normal Electronic Health Records (EHR) system workflow, to be notified of a REMS and its applicable elements to assure safe use at the appropriate time – in this use case, when ordering a medication for a REMS covered drug.

In addition to being notified, the prescriber is also presented with an application user interface, still within their EHR and without the need for additional logins, etc., to supply the information required for the Elements to Assure Safe Use (ETASU), in this case a patient enrollment. 

 “A key component of this use case, championed by the U.S. Food and Drug Administration, is automating interoperable exchange of standardized REMS data” said Saneel Vasram, Program Director, CodeX. “The shared CodeX vision and community-driven effort to reduce REMS clinical workflow burden, technical implementation effort and improved quality of REMS data is integral to optimizing safe medication use and health outcomes.”

Within the just-in-time prompt and in workflow user interface, most if not all the data can be supplied directly from the EHR to the REMS form and the prescriber data entry will be eliminated or severely reduced.  “This creates enormous value for a REMS implementation by reducing burden to prescribers, patients, and indirectly pharmacies, as their patients will be more likely to arrive at the pharmacy with the proper ETASU documentation in place,” said Ms. O’Donnell. The streamlined process will improve compliance and therefore overall safety.

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.

Media Contact:

Amber Frasketi

Head of Marketing & Strategic Communications

UBC

(215) 588-8423

amber.frasketi@ubc.com

About CodeX

As an HL7^® FHIR^® Accelerator, CodeX is a community on a mission to leverage standards to unlock the power of real-world clinical data so that patients can have the care and research journeys they deserve and should expect. CodeX advances FHIR standards in clinical specialty domains such as cancer, genomics, and cardiovascular health across a wide breadth of use cases that includes real world endpoints for cancer clinical trials, cancer clinical trial matching, registry reporting, etc. With tremendous strides forward in vendor adoption, early use in routine patient care, and an expanding domestic and international community, CodeX is looking for new members as we bring clinical health interoperability to the next level. Get engaged by reaching out to CodeX@hl7.org. Learn more at https://codex.hl7.org/.

Media Contact:

Saneel Vasram

Program Director

CodeX HL7 FHIR Accelerator

saneel.vasram@hl7codex.org

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AUSTIN, Texas and BLUE BELL, Pa., Aug. 1, 2023 / — 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.

For more information about The Safety Innovation Summit Europe 2023, which is open to all safety professionals involved in pharmacovigilance, click here.

For more information about Oracle Argus Cloud Service, click here. For more information about Oracle Cloud Infrastructure, click here.

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 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. For additional information, visit www.ubc.com.

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’ 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 help 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.

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.

¹ Ernst & Young, “How robotics is reshaping the biopharma value chain” – click

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UBC was recognized in the 2023 CRO Leadership Awards by both small and big pharma as a winner in the Reliability category. This category recognizes companies that exceed customer expectations in meeting overall project timelines, operational excellence, and staff turnover. UBC was previously recognized for these awards for our work in Phase IV research in 2018 and 2019.

The CRO Leadership Awards are Clinical Leader and Life Science Leader’s industry awards backed by a quality benchmarking survey sent to pharmaceutical companies by ISR Reports. UBC is honored to be recognized by our customers from the past 18 months as an overall winner in the Reliability category.

At the awards ceremony during DIA’s Global Annual Meeting, Head of Evidence Development Aaron Berger sat down with Penelope Przekop from PDC Pharma Strategy to discuss the award, what it means for UBC, and what helps drive UBC’s reputation in the industry.

Congratulations to UBC’s Evidence Development team on this accomplishment! Learn more about UBC’s research services that operate at the intersection of access and evidence here.

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Seattle and Blue Bell, P.A., June 27, 2023 – Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, and United BioSource LLC (UBC), a leading provider of evidence development solutions for the biopharmaceutical industry, today announced a partnership to provide more efficient, streamlined, and convenient sample collection and analysis options for post-approval research to improve study design and enable a better patient experience.

The new partnership will bring together Tasso’s devices for at-home, virtually painless clinical-grade blood sample collection and end-to-end collection and analysis solutions with UBC’s late-stage research expertise in evidence development and participant support services, including digital recruitment and engagement strategies, powerful real-world data infrastructure and rapid analytics software. Together, the two companies will offer a complete solution for biopharmaceutical companies seeking to improve participant retention and compliance, boost patient engagement, and enroll more diverse patient populations in decentralized post-approval studies.

Tasso and UBC have recently been awarded a late-stage biomarker monitoring study, with additional projects expected to follow.

“This collaboration combines UBC’s expertise in modernized study design and execution with our innovative offerings to create an unprecedented new solution for patient-centric, decentralized research,” said Ben Casavant, PhD, CEO and co-founder of Tasso, Inc. “Importantly, the collaboration will not only provide sponsors with the high-quality data they require but will also drive much-needed improvement in the patient experience and trial participant diversity.”

Research utilizing the joint offering will be powered by Tasso’s integrated solutions to streamline blood sample collection and analysis. After sponsors provide a list of samples needed, Tasso will handle shipping at-home blood collection kits directly to research participants, manage transport of samples to an analytical laboratory that has validated the specific test(s) needed, and communicate lab results back to the sponsor. The fully integrated Tasso Connect portal will ensure samples can be tracked with out-of-the-box functionality, and for seamless connectivity, partners can link with their own systems through Tasso’s API integration.

“With today’s rapidly evolving post-approval drug development requirements, there’s a real need to help sponsors efficiently, effectively, and safely execute and manage late-stage and real-world evidence generation research programs that meet regulatory and payer requirements and support their product commercialization objectives,” said Aaron Berger, Head of Evidence Development, UBC. “Our partnership with Tasso allows us to collectively provide flexible, integrated, and innovative offerings that improve the patient experience and advance decentralized research methods.”

About Tasso

Tasso is an emerging healthcare technology company that is transforming the traditional blood collection paradigm with a patient-centric approach. The company’s devices enable simple, convenient, and virtually painless blood collection for users. Tasso technology has the power to bring healthcare anywhere, any time. Headquartered in Seattle, Washington, Tasso is privately held and funded by grants, investments, and co-development deals with various industry leaders. For more information, please visit www.tassoinc.com.

Media Contact:

Dina Schneider

Tasso, Inc.

(206) 822-4186 x1016

media@tassoinc.com

About UBC

United BioSource LLC (UBC) is the leading provider of evidence development solutions with an expertise in unifying 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 https://ubc.com/.

Media Contact:

Amber Frasketi

UBC

(215) 588-8423

amber.frasketi@ubc.com

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