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Article | Tuesday, May 19, 2020
A major biopharmaceutical company selected UBC’s home health nurse network to mitigate concerns that the COVID-19 public health emergency and shelter-at-home mandates would prevent patients from receiving their next dose of a healthcare provider-administered product within the critical dosing window.
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Article | Tuesday, May 19, 2020
A comprehensive PV strategy, requires a depth of understanding not only in terms of the complex and rapidly evolving safety landscape, but also in new tools and approaches that may significantly streamline and simplify workflows.
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Article | Tuesday, May 19, 2020
UBC efficiently and strategically manages a global rare disease registry with rolling start-up, including mandated annual data collection and reporting. For more than six years, UBC has been conducting a long-term global product exposure registry for patients with homozygous familial hypercholesterolemia (HoFH).
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Case Study | September 9, 2020
A major biopharmaceutical company selected UBC’s home health nurse network to mitigate concerns that the COVID-19 public health emergency and shelter-at-home mandates would prevent patients from receiving their next dose of a healthcare provider-administered product within the critical dosing window.
Blog | August 17, 2020
The right strategy to continually evaluate product safety in your clinical trials, through regulatory review and entering the post-marketing setting, is complex. Are you ready?
Blog | August 5, 2020
Recent studies cite that 80% of trials are delayed due to patient recruitment challenges, with up to 20% of enrolled sites never enrolling a single patient.
Case Study | July 30, 2020
UBC efficiently and strategically manages a global rare disease registry with rolling start-up, including mandated annual data collection and reporting. For more than six years, UBC has been conducting a long-term global product exposure registry for patients with homozygous familial hypercholesterolemia (HoFH).
Blog | July 29, 2020
A comprehensive PV strategy, requires a depth of understanding not only in terms of the complex and rapidly evolving safety landscape, but also in new tools and approaches that may significantly streamline and simplify workflows.
Blog | June 22, 2020
Pharmaceutical and biotech companies benefit from working with external partners to manage pharmacovigilance activities. The breadth and scope of required services can depend on the mix of investigational and marketed products, the size of the company, and their comfort with outsourcing safety. Organizations realize a variety of benefits when collaborating with an external partner for safety services.
Blog | June 19, 2020
UBC’s Dr. Annette Stemhagen received well-deserved recognition at this year’s DIA Global Annual Meeting with an Excellence in Service Inspire Award.
Blog | June 5, 2020
Amid the current health crisis, we are now facing the pain and heartache of the senseless killing of George Floyd. Unfortunately, we know that there are other black victims like him with no one being held accountable.
Blog | June 4, 2020
Near the end of April, the FDA reported 72 active clinical trials for potential coronavirus treatments and an additional 211 programs in the planning stages.
Press | May 21, 2020
UBC, a leader in global late-stage and patient support services for the biopharmaceutical industry, introduces UBC Pathways® Engage – a digital concierge that transforms traditional patient education, support and communications through a combination of proprietary engagement methodologies and mobile messaging technology. UBC Pathways® Engage is purpose-built to help patients start and stay on therapy.
Articles | May 19, 2020
Vaccine trials have unique requirements; therefore, careful consideration must be given to the design, planning, preparation and execution of these studies.
Blog | May 7, 2020
Once again, UBC’s Patient & Physician Services (PPS) Creative Services Department has been recognized for excellence in advertising and marketing for their standout work.
Blog | April 22, 2020
During a recent meeting with UBC’s president, a fellow employee asked how UBC could help during the COVID-19 crisis. As pharmacovigilance physicians and nurses, many of us were formerly working in direct patient care and are struggling a bit with the fact that we aren’t on the frontline efforts.
Articles | April 16, 2020
For visits that must continue to occur at the site due to complex assessments with specialized equipment and physician-administered treatment, we have developed a thorough set of best practices.
Blog | March 31, 2020
There has been much in the news about why the COVID-19 virus (officially known as SARS-COV2) death rates (also known as mortality rates) differ so much by country, and that the true infection rates are probably vastly undercounted.
Blog | March 26, 2020
In this time of a viral pandemic, it is still important to keep a focus on rare diseases. Every last day of February is Rare Disease Day, the biggest day of the year for the rare disease community. Since 2009, the National Institutes of Health (NIH) Clinical Center and National Center for Advancing Translational Sciences (NCATS) have hosted Rare Disease Day at the NIH as part of the global observance to focus the world’s attention on this important subject.
Blog | March 23, 2020
I was pleased to be a part of the Duke-Margolis webinar on January 15, 2020 entitled, "Bolstering RWE Study Credibility and Its Role in a Totality of Evidence Approach," and thought it important to share some of the learnings from the session.
Press | March 18, 2020
United BioSource LLC’s Communication to Clients and Business Partners on COVID-19 Pandemic.
Blog | March 13, 2020
In February 2020, the International Society for Pharmacoepidemiology (ISPE) released a position statement on Real World Evidence (RWE).
Blog | February 25, 2020
In a recent article published, “Discrepancies Between the Labels of Originator and Generic Pharmaceutical Products: Implications for Patient Safety”, UBC’s Drs. Alexandra Thoenes, Luca Cariolato and Alexis Pinçon examined the degree of difference between the labels of products from different marketing authorisation holders, both generic and originator products, and analysed the possible impact of these differences on patients' health and the implications for risk mitigation.
Blog | February 4, 2020
During the 12th REMS Summit in Virginia, UBC’s Natalie O’Donnell, Corporate Vice President, Safety, REMS, and Strategic Engagement and Justin Wilson, Director, Software Development and Technology, presented a session on the impact technology has had on REMS and the potential effect it can have in the future. They discussed how technology has become transformative, reducing patient and health care professional burden and improving compliance with REMS requirements.
Blog | December 19, 2019
In this podcast, “Partnering to Develop and Implement a Global Risk Management Plan – What You Need to Know“, UBC’s Dr. Janine Collins, Executive Director, Safety, Epidemiology, Registries and Risk Management speaks to the importance of risk management plans and key considerations and benefits to outsourcing a global risk management plan/program.
Case Study | December 12, 2019
This case study demonstrates development and implementation of a strategic partnership to execute a portfolio of heart failure studies to accompany an evidence generation program for a new product launch.
Articles | December 10, 2019
UBC's thought leaders recently appeared in PharmaVOICE speaking to the importance of registries in rare diseases.
Blog | November 21, 2019
For more than 20 years working in patient support services, I have touched an expansive array of therapies and therapeutic areas, making my experience both broad and deep.
Case Study | October 8, 2019
UBC successfully provided Hub services to ease the barriers to access and simplify a very complex treatment initiation in pediatric patients suffering from SMA.
Blog | October 3, 2019
An October 1 announcement of FDA’s funding of $220 Million to the Harvard Pilgrim Health Care Institute for the next phase of FDA’s Sentinel System brings continued focus on FDA’s commitment to evaluating Real World Evidence (RWE) for informing prescribers and patients about product safety.
Blog | October 2, 2019
Patients are the heart of clinical research. It is important to understand factors affecting the patient outside of the clinical trial setting to better understand the disease, patient, and caregiver.
Case Study | September 18, 2019
UBC Successfully Exceeded Enrollment Targets by 60% in Phase IV Acne Study
Case Study | September 18, 2019
UBC Successfully Managed Global Observational Study with Customized Service Offerings.
Case Study | September 6, 2019
UBC successfully managed a large global phase III clinical trial in patients with mCRC refractory to standard chemotherapies.
Blog | September 3, 2019
Immune responses toward therapeutic proteins may cause significant adverse effects, such as loss of efficacy, hypersensitivity and autoimmunity. For that reason, it is imperative to assess the potential of therapeutic proteins along and beyond the pre-clinical and clinical development phases.
Blog | August 1, 2019
UBC is pleased to announce that Sallyanne Williams, SVP & Head of Global Late Stage Services, was named an honoree of PharmaVOICE's 100 Most Inspiring People.
Videos | July 30, 2019
UBC's Wenda Brennan, VP, Global Pharmacovigilance & Safety took part in a PharmaVOICE interview during the Annual DIA Conference in San Diego, CA.
Videos | July 17, 2019
UBC was pleased to connect with so many industry colleagues at DIA. We look forward to continuing the conversation.
Blog | July 9, 2019
Now more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources, we find products are commercialized and made available in new markets – having a strong real-world infrastructure to accommodate all these sources, modalities, and connections is of great importance to your late stage development evidence-generation strategy.
Whitepapers | June 28, 2019
In this whitepaper, UBC thought leaders speak to how standardizing and linking disparate real-world data into a common data model yields greater understanding of rare diseases and their treatments.
Blog | June 4, 2019
UBC was pleased to receive numerous Healthcare Marketing Report’s 36th Annual Healthcare Advertising Awards for their exemplary work.
Blog | June 3, 2019
A.K. Gupta, SVP & CIO, UBC recently contributed to PharmaVOICE’s June issue on the topic of “Clinical Trial Solutions: Technology Disrupters.
Press | May 7, 2019
UBC exceeded customer expectations in Phase IV clinical research, according to ISR's CRO Quality Benchmarking annual online survey.
Blog | May 3, 2019
I was pleased to recently attend, in the role of a facilitator, a 4-week course on malaria to health care professionals (HCPs) at Ifakara Health Institute (IHI), Bagamoyo branch in Tanzania, which is a successful collaborative effort between the Swiss Tropical and Public Health Institute (Swiss TPH) and the Ifakara Health Institute.
Whitepapers | April 17, 2019
In this whitepaper, UBC discusses pregnancy exposure registries (PERs) as an approach to discerning data on the safety and efficacy of a product.
Whitepapers | April 17, 2019
Gaining access to specialty medications requires navigating multiple complex pathways, including determining insurance coverage options, co-pay amounts, the patient’s total cost of therapy, prior authorizations, and appeals.
Whitepapers | April 17, 2019
Six experts working in patient recruitment, clinical development, drug safety, product launch, and commercialization review unique hurdles faced in the rare disease market.
Videos | April 5, 2019
Dr. Annette Stemhagen, SVP & Chief Scientific Officer, speaks to Pregnancy Exposure Registries (PERs) and why partnering with an experienced team is so vital.
Blog | April 4, 2019
A REMS should be considered when risk mitigation efforts are required beyond product labeling and routine pharmacovigilance.
Videos | April 4, 2019
In this video, Dr. Stemhagen discusses the differences between Observational and Investigational Studies.
Videos | April 3, 2019
Natalie O'Donnell, Executive Director, Safety, Epidemiology, Registries, and Risk Management provides a REMS overview.
Blog | April 1, 2019
UBC's eBV solution is now benefitting more patients than ever before with its expanded connections.
Articles | April 1, 2019
In a recent article in PharmaVOICE's Patient Issue, UBC's SVP, Patient Support Services, Nicole Hebbert speaks to Patients' Voices: Storytelling.
Articles | April 1, 2019
Shazia Ahmad, Director, Patient and Physician Services, is featured in a recent article on patient advocates.