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Article | April 14, 2021
With the complexity of gene and cell therapy, there must be alignment between multiple stakeholders related to collaborating and communicating for the sake of the patient’s treatment.
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Article | April 12, 2021
Dana Edwards, UBC's VP of Patient Access and Strategic Engagement, sat down with Pharmaceutical Commerce to discuss how to keep your engagement strategies in line with the evolving needs of patients.
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Article | March 31, 2021
Rare Disease Day 2021 was an opportunity to see how collaboration, health literacy, and technology can progress rare disease treatment. Most importantly, this day enabled stakeholders to reinvigorate our passion to advance treatments for rare disease patients and reminds us that the patient is the central point of our work.
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Blog | April 14, 2021
With the complexity of gene and cell therapy, there must be alignment between multiple stakeholders related to collaborating and communicating for the sake of the patient’s treatment.
Articles | April 12, 2021
Dana Edwards, UBC's VP of Patient Access and Strategic Engagement, sat down with Pharmaceutical Commerce to discuss how to keep your engagement strategies in line with the evolving needs of patients.
Blog | March 31, 2021
Rare Disease Day 2021 was an opportunity to see how collaboration, health literacy, and technology can progress rare disease treatment. Most importantly, this day enabled stakeholders to reinvigorate our passion to advance treatments for rare disease patients and reminds us that the patient is the central point of our work.
Whitepapers | March 17, 2021
Read the joint article from UBC and Informa about how to successfully harness the power of real world evidence generation techniques. This free article breaks down the three key ingredients to the successful creation of evidence generation strategies
Press | February 17, 2021
UBC is announcing an offering to harness the power of real-world data (RWD) for rapid generation of insights into the safety and effectiveness of COVID-19 vaccines.
Articles | February 8, 2021
UBC, a leading provider of pharmaceutical support services, convened a virtual gathering of experts for an invigorating discussion on the use of external comparators in clinical research and post-marketing programs.
Press | January 22, 2021
According to UBC’s Ron Lacy VP, Products & Innovation, “Where we have deployed this technology, we are seeing 95% positive patient sentiment in response to the inclusion of mobile messaging in the patient’s therapy journey, along with improved patient outcomes."
Articles | January 12, 2021
UBC is proud to be a founding member of the DTRA and accelerate the broad adoption of patient-focused, decentralized clinical trials and research.
Case Study | November 17, 2020
UBC is currently managing an AML / MDS disease registry for a leading biopharmaceutical client with 200 sites working toward an enrollment target of 2,100 patients across three cohorts. The study has been ongoing for eight years to provide insights from current and evolving treatment regimens, and the impact on prognosis and health-related quality of life.
Press | November 4, 2020
UBC has launched a flexible, full-service solution that enables prescribers to enroll patients directly into patient support programs without having to leave their existing electronic health record (EHR) prescription workflow.
Case Study | November 3, 2020
UBC was selected by a mid-size pharmaceutical company to provide pharmacovigilance services for six oncology products. Data from two legacy vendors and multiple sources, including four specialty pharmacies and six license partners, had to be migrated to the new pharmacovigilance system.
Articles | October 21, 2020
Nicole Hebbert (SVP, Head of Patient Support Services, UBC), Jennifer Lim (Director of Patient Services, UBC), UBC partner SK Life Science and various industry experts spoke with PharmExcec.com about the impact a patient support program or ‘Hub’ can have on patients and prescribers during a pandemic.
Articles | October 8, 2020
Recently, we spoke with Jersino Jean-Mary, Executive Director, European Late Stage Operations Team, and Aaron Berger, Executive Director, North American Late Stage Operations Team to discuss how the COVID-19 global health crisis is impacting the future of virtual and decentralized studies.
Articles | October 6, 2020
UBC recently participated in a smallpox safety surveillance study. This prospective study included the enrollment 20,136 subjects who were active-duty military personnel undergoing pre-deployment medical readiness.
Blog | September 24, 2020
Rachel Sobel, DrPH, FISPE VP, Epidemiology examines the Recent Duke-Margolis white paper: A Roadmap for Developing Study Endpoints in Real-World Settings.
Whitepapers | September 21, 2020
Download our white paper today to read a few of the key lessons learned from our experience implementing and designing more than 120 RiskMAPs and REMS programs.
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 | September 4, 2020
A REMS should be considered when risk mitigation efforts are required beyond product labeling and routine pharmacovigilance.
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 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 eased the barriers to access and simplified a very complex treatment initiation in pediatric patients suffering from SMA through our patient support services.
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
As a result of UBC's proactive management of a Phase IV adolescent acne study by mitigating potential study challenges relative to the age of the participants, the enrollment goal was not only achieved, but exceeded by 60%.
Case Study | September 18, 2019
UBC enrolled subjects in a global observational cohort study for patients with moderate-severe psoriasis who are initiating or switching to a new biologic. Enrollment required a 5 year commitment (2 year enrollment, 3 year follow-up).
Case Study | September 6, 2019
UBC managed a large global phase III clinical trial in patients with mCRC refractory to standard chemotherapies. The target was to randomize 800 patients in an 18-month period and the trial ran in 113 sites, across 13 countries.
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.
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.
Articles | March 27, 2019
Bruce Smith, Executive Director of Scientific and Medical Strategy, recently spoke with PharmaVOICE on rare disease concierge approaches to patient access.
Press | March 26, 2019
UBC’s eBV solution is now benefiting more patients than ever before with its expanded connections.
Blog | March 18, 2019
UBC is introducing PVPlan™ automated software for signal management and tracking for pharmacovigilance (PV). The easy-to-use, point-and-click interface lets you track and manage your PV team with ease, while enhancing inspection readiness and compliance with regulatory requirements.
Blog | March 14, 2019
Traditionally, sources of adverse event reporting included the clinical trial investigator sites, post marketing medical information call centers, and local QPs in Europe.
Blog | March 7, 2019
Rare Disease Day is the biggest day of the year for the rare disease community. Since 2009, the National Institutes of Health (NIH) Clinical Centerand National Center for Advancing Translational Sciences (NCATS) have hosted Rare Disease Day at the NIH as part of the global observance.
Blog | March 1, 2019
The Summit for Clinical Ops Executives (SCOPE) is one of the few conferences that focuses on the challenges of patient recruitment and retention for clinical research. This year’s event, held in Orlando, FL, Feb 18-21, brought together more than 1,800 stakeholders including representatives from pharma, CROs, NIH, and an array of clinical research specialty vendors.
Webinar | February 27, 2019
Irene Cosmatos, Senior Research Specialist, Database Analytics Automation and Dr. Ruben M. Ayzin Rosoky, Senior Safety Physician, present a webinar on the role of RWD after safety signals are identified.
Blog | February 26, 2019
EudraVigilance is the key organizational construct for the European Economic Area (EEA) and is anchored by a central database containing safety reporting (adverse events) and suspected unexpected serious adverse reactions (SUSARs) for marketed products and investigational drugs in clinical trials.
Blog | February 22, 2019
Last week, leaders and scientists from the biotech and pharmaceutical industry gathered in San Francisco at the Outsourcing in Clinical Trials - West Coast Conference to share ideas and discuss recent trends in the clinical trial landscape.
Blog | February 18, 2019
UBC, a global leading provider of late-stage and patient support services, held a ribbon-cutting ceremony for the grand opening of a 43,000 square foot facility located at 680 Century Point, Lake Mary, FL due to expansion of the business.
Blog | February 1, 2019
February 4th is World Cancer Day, a global event on which we are united to spread awareness, education, and hope as it relates to this insidious disease.
Videos | January 25, 2019
UBC is pleased to announce the expansion of its offerings with a new state-of-the-art 43,000 square foot facility embedded in Lake Mary, Florida.
Blog | January 22, 2019
UBC’s Clinical Project Director in the EU, Van Zyl Engelbrecht, recently took part in a PharmaVOICE podcast on, “Successfully Managing & Implementing Orphan Drug Development Programs.”
Whitepapers | January 4, 2019
This whitepaper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.
Webinar | January 3, 2019
Bringing the Study to the Patient: Adoption of Virtual Concepts in Study Design to Optimize the Conduct of Clinical and Observational Research
Blog | December 7, 2018
We are pleased to announce that Wenda Brennan, RPh, has rejoined UBC as our Vice President, Global Safety and Pharmacovigilance.
Blog | November 6, 2018
When faced with complex topics, we’re hardwired to choose information that’s easier to absorb. And in the medical field, a well-designed video can mean the difference between a patient opting in or opting out of a clinical trial.
Blog | November 1, 2018
Recent studies cite that an estimated 43.5 million adults in the United States have provided unpaid care to an adult or a child in the prior 12 months. About 18.2% of the respondents surveyed reported being caregivers1.
Blog | November 1, 2018
The NORD Rare Disease Summit is something I look forward to each year. It is a time to share and discuss all that we each do in the rare disease community−whatever area we work in, be it drug development, clinical research, regulatory compliance or patient advocacy.
Blog | October 19, 2018
Real World Evidence is accelerating researchers’ ability to answer important questions about the safety and effectiveness of medical treatments through improved clinical trial design and execution.
Blog | October 12, 2018
United BioSource, LLC (UBC), (www.ubc.com) a leader in hub services technology, announces the release of UBC Pathways™ Connected Health 2.0.
Blog | October 5, 2018
With summer behind us, many of our clients are focused on year-end milestones. Whether it’s first patient randomized in a new study, or meeting the study enrollment goal, or a target number of sites activated.
Blog | October 2, 2018
UBC’s Ron Lacy, Vice President, Product and Service Development took part in a Think Tank interview on Patient Support Programs alongside ten other industry experts.
Blog | October 2, 2018
Nancy Mulligan, Executive Director, Patient and Physician Services recently contributed to an article in PharmaVOICE, an online publication, on Trial Sites and Patient Diversity.
Blog | July 23, 2018
In late June, leaders and scientists converged at the recent Drug Information Association Conference in Boston, Massachusetts, to share ideas and discuss recent trends in the clinical trial landscape. Interest continues to revolve around Real World Evidence.
Blog | June 4, 2018
Leaders and scientists converged at the recent Outsourcing in Clinical Trials East Conference in King of Prussia, Pennsylvania, to share ideas and discuss recent trends in the clinical trial landscape. One prominent topic continues to revolve around Real World Evidence.
Blog | March 20, 2018
Each year since 2009, the National Institutes of Health (NIH) Clinical Center and National Center for Advancing Translational Sciences (NCATS) has hosted Rare Disease Day at the NIH to participate in the global observance.
Blog | March 20, 2018
In the Rare Disease space, a product NDC may change for any of several reasons. Whether it’s a new product formulation on the market or a new company inheriting a previously established product, it’s imperative to think through the potential impact that a product NDC change may have on your established patient population.
Blog | November 2, 2017
I look forward to the NORD Rare Summit each year. It is a time to reflect on the work all of us do in the rare disease community−whatever area we work in, be it drug development, clinical research, regulatory compliance or patient advocacy.
Blog | October 24, 2017
It’s been just about a year since UBC launched UBC Pathways, our proprietary suite of healthcare analytics and technology solutions that help patients access their medications as quickly as possible and stay adherent to their therapy.
Blog | October 13, 2017
If you haven’t noticed UBC in the news lately, you may not be looking hard enough. Our experts have been busy talking to media in the industry, sharing insights you don’t want to miss. Here are articles published this month with contributions from four of UBC’s thought-provoking experts.
Blog | October 2, 2017
The growth of social media interactions has played a critical role in advancing knowledge and awareness of rare and orphan diseases. Social media tools have helped stakeholders working in rare disease clinical development to increase awareness of diseases or identify patients for clinical trials.
Blog | September 20, 2017
UBC was contracted to provide clinical trial nursing services in a pivotal Phase III rare autoimmune disease trial. As this indication affects less than 2% of the population, ensuring that enrolled patients completed study requirements without loss-to-follow up was crucial. The study was designed to assess the efficacy and safety of the study drug compared with placebo in adults who had been receiving the study drug via a separate open label trial.
Blog | August 1, 2017
Annette Stemhagen, DrPH, FISPE, Vice President, Safety, Epidemiology, Registries & Risk Management, goes the extra mile for clients, working to improve drug safety and patient access to therapies.
Blog | July 31, 2017
Professionals working in the field of Pharmacovigilance traditionally collect and assess reports of potential adverse events based on information received from healthcare providers’ interactions with patients.
Blog | July 18, 2017
More and more, sponsors recognize the importance of leveraging a successful patient recruitment and retention strategy from the beginning of a research program.
Blog | June 15, 2017
Manufacturers of biopharmaceutical products and medical devices understand that the regulatory approval of their product will bring postmarketing challenges, requiring strategic and innovative solutions for continued surveillance of product safety and for demonstrating value and effectiveness based on real world evidence.
Articles | March 1, 2015
In this ICT article, UBC's Nancy Mulligan, Sr. Director and Patrick Prugh, Senior Web Designer, Patient & Physician Services (PPS), discuss the increasing trend of mHealth.
Blog | March 1, 2015
Apple introduced its ResearchKit, a new software platform for patient recruitment, at its “Spring Forward” event last week. It features 5 apps – asthma, Parkinson's disease, diabetes, breast cancer and cardiovascular disease. As one of the hundreds of millions of iPhone users, and a member of the clinical research community, I was eager to check them out.