Lessons Learned When Implementing a REMS Program
Leverage UBC’s 120+ REMS program lessons for seamless implementation. Learn key strategies for risk planning, compliance (IRB, FDA), and integrating REMS into healthcare.
Personalized Medicine: A Primer on the Role of Pharmacogenetics and Pharmacogenomics in Oncology
Explore how pharmacogenetics and genomics are transforming cancer treatment, reducing adverse drug reactions, and advancing targeted therapy development safely.
Recently Approved Cell-Based Gene Therapies Demonstrate Innovation in Sickle Cell Disease Treatment
This white paper offers a comprehensive primer on the burden of SCD, the patient journey, and current and emerging treatment options.
Understanding the Natural History of Disease
Learn more about the benefits of natural history studies in drug development.
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.
