ABOUT UNITED BIOSOURCE LLC

United BioSource LLC (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. UBC is well known for our expertise in generating authoritative, real-world evidence of product effectiveness, safety, and value to assist healthcare decisions and enhance patient care. We understand what it takes to compete in a crowded product market with many stakeholders that demand the right evidence at the right time.

PRODUCTS

Regulator and payer constituencies have recognized the immense potential of real world evidence (RWE) in accelerating our ability to answer important questions about the safety and effectiveness of medical treatments. The opportunity to capitalize on RWD/RWE goes beyond the regulatory domain. Payer demand for evidence to support a product’s value proposition is growing, in part due to proliferation of value-based reimbursement models. In addition, the 21st Century Cures Act mandates that FDA explore the use of RWE to expand indications for approved drugs and to fulfill post approval requirements.

UBC understands the challenges surrounding registries and other real-world data studies. Our epidemiological approach to registries and other non-interventional studies focuses on collecting relevant data to understand the natural history of the diseases for which treatments are being developed, and the real-world use of medicinal products in the post-marketing period, either as an ad hoc study, in electronic medical records, or by leveraging existing databases and registries.

UBC helps pharmaceutical and biotech manufactures overcome access and adherence challenges by using the right combination of our high-touch services and high-tech solutions. Our patient support programs are powered by UBC Pathways™, our proprietary suite of healthcare analytics and technology solutions.

Obtain regulatory approval through innovative research methods that maximize ROI

Led by industry safety expert, Annette Stemhagen, DrPH, FISPE, UBC’s Risk Management, Registries & Epidemiology team brings unmatched passion and commitment to your product and your reputation. 

VIDEOS

The biopharmaceutical industry is rapidly adopting methodologies that decentralize research by harnessing transformative data acquisition and patient engagement thus taking the research beyond the walls of the legacy study setting. To truly realize the promise of decentralized research models, a dynamic array of technological capabilities, traditional research core competencies, and innovative study design expertise is required. Join us as we explore operational challenges, technical solutions, and design considerations.

This video explains how a fully integrated solution is driving the trend towards decentralized clinical trial (DCT) designs and tactics to support phase II-IV clinical trials, pragmatic studies, and late-stage observational research. 

We have only just begun to scratch the surface of the potential of the electronic medical record (EMR) to support research and evidence generation in the realm of drug development. During this discussion, we examine several practical applications of real word data from EMRs to support research.

Learn how to overcome the challenges of combining multiple registries to generate richer data in order to better understand disease progression and real world practice patterns.

Population-based RWD are increasingly used by US and EU regulators to complement passive safety surveillance that is based on review of adverse event spontaneous reports. The presentation focuses on a recommended analytic approach for safety scientists, epidemiologists, and other researchers for evaluating the causality of a signal identified from one or more data sources.

Virtual study designs are transforming the way biopharmaceutical businesses conduct research. Tactics that decentralize the approach to clinical and observational research are ushering in a new paradigm of efficient data collection and patient centric engagement.

UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.

Dr. Annette Stemhagen, SVP & Chief Scientific Officer, speaks to the differences between Interventional and Observational Studies.

Dr. Annette Stemhagen, SVP & Chief Scientific Officer, speaks to Pregnancy Exposure Registries (PERs) and why partnering with an experienced team is so vital.

CONTACT INFORMATION

United BioSource LLC (UBC)

920 Harvest Dr, Suite 200

Blue Bell, PA 19422

UNITED STATES

Phone: 215-687-7315

Contact: Mike Montagnon

NEWS