The Joint Clinical Assessment: Anticipating Challenges and Opportunities
This white paper provides an essential overview of the regulations, a brief history, and an in-depth look at the EU’s Health Technology Assessment Regulation 2021/2282.
Gain Strategic Insights by Linking Clinical Trial Data to Real World Data
Read our white paper to explore how integrating RWD/RWE with clinical trial data can overcome challenges and enhance regulatory submissions.
The FDA Expands Confirmatory Evidence: Your Strategy to Expedite Drug Effectiveness Approval
Get the guide to strategic real-world evidence design, integration, and regulatory analytics. Learn how real-world data and natural history studies can expedite your drug’s approval.
Understanding the Importance of Utilizing Social Determinants of Health
This white paper explores using the elements of social determinants of health (SDOH) to create optimal patient services program design.
Improve Patient Diversity and Expand Access in a Real-World Setting
Boost enrollment in clinical studies that reflects the diversity of the population who will use the medical product.
Global Evidence Generation Checklist
Help guide internal conversations and begin to assess evidence gaps for your therapeutic with UBC’s Evidence Generation Checklist.
Planning Real-World Studies to Support Cell and Gene Therapy Evidence Generation Needs
Overcome Cell and Gene Therapy (CGT) study challenges by using strategic real-world data and real-world evidence (RWD/RWE) planning to construct external controls, integrate registries for long-term follow-up (LTFU), and demonstrate product value to regulators and payers.
Optimizing the Patient Journey Through High-Tech, High-Touch Services
Learn to balance personal connection and technological efficiencies for improved patient adherence, access, and affordability solutions in this whitepaper.
How to Start Your Real-World Evidence Journey
Figure out how to maximize product value with early, integrated RWE planning.
