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

Real World Evidence/Real World Data Real World Evidence/Real World Data

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.

Registries And Observational Studies Registries And Observational Studies

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.

Patient Access & Engagement Services Patient Access & Engagement Services

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.

Clinical Development Solutions Clinical Development Solutions

Obtain regulatory approval through innovative research methods that maximize ROI

Risk Management & Pharmacovigilance Risk Management & Pharmacovigilance

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

Risk Evaluation And Mitigation Strategy (REMS) Overview Risk Evaluation And Mitigation Strategy (REMS) Overview

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.

Interventional vs. Observational Studies Interventional vs. Observational Studies

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

Pregnancy Exposure Registry Pregnancy Exposure Registry

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

More Videos