UBC has focused on drug safety evaluation with RWD for more than 15 years and is aligned with FDA’s Sentinel Initiative. UBC’s safety scientists and epidemiologists provide comprehensive and customized RWD solutions to evaluate the safety of your marketed products.
Implementing an enterprise-wide Real World Evidence strategy is essential to meet the growing demands of regulators, patients, healthcare providers and payers to support approval, treatment decisions and reimbursement. Fluency in evidence-generation combined with operational expertise in RWE are crucial for capitalizing on the potential RWE has to offer.
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 offers strategic, scientifically rigorous studies designed to address stakeholder-driven evidence requirements. UBC is an industry leader in pharmacoepidemiology, including the design and global implementation of observational cohort studies, registries, large streamlined studies and other observational programs, such as ad hoc studies, database studies and chart reviews.
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.
You are at a significant milestone as you advance your therapy from lab to patient. It is a hopeful, promising moment — an excitement we share with you. For more than 20 years, Bellwyck has been a true partner in developing smarter solutions for the pharmaceutical industry — from clinical trial to commercialization.
Your own dedicated project management team
For more than 25 years, Bellwyck has been a true partner in developing smarter solutions for the pharmaceutical industry — from clinical trial to commercialization. Our consulting services start with a dedicated project management team led by a single point of contact throughout your project.
Packaging your trial
We understand that labeling and packaging your trial drug is an intricate and vital piece of your project. While the clinical supplies packaging industry has changed substantially over time, we make sure our experts keep up-to-date and understand how these changes affect your packaging needs.
Cold-chain logistics expertise
Our GMP-compliant storage capacity, cold-chain logistics expertise and global distribution capabilities means we can fulfill your unique needs no matter the size or scope of your project.
While regulatory compliance is a major driver for serialization projects, breaches to the Pharmaceutical Supply Chain distribution system are also a concern, as they can pose health risks to patients and financial risks to the supply chain stakeholders. At Bellwyck, our holistic and comprehensive approach to serialization ensures these risks will be mitigated and will maximize your value.
|
|
|
|
|
|
|
|
|