Rethinking Decentralization in Direct-to-Patient Studies: A Conversation with Aaron Berger
Explore how UBC is leading the transformation of clinical research through decentralized, direct-to-patient study designs. In this interview, Aaron Berger shares insights on improving patient access, data quality, and trial efficiency through UBC’s Evidence Development Solutions.
Beyond Enrollment Woes: Why Sponsors Seek Rescue in Tumultuous Times
Rescue studies are a challenge, and often enrollment is a top reason for switching. But mismatched partnerships go beyond enrollment.
Regulatory Submissions with Real-World Evidence: Highlights from the Joint Duke Margolis Institute and FDA Public Meeting
As Real World Evidence (RWE) continues to shape regulatory decision-making, the FDA and Duke Margolis Institute convened a public meeting to share successes, challenges, and lessons learned in RWE submissions. With over 4,000 attendees, the event spotlighted case studies, data feasibility, and the evolving role of RWE in labeling, post-marketing commitments, and registrational trials. Learn how sponsors are partnering with regulators to modernize study design and advance global RWE standards.
Optimizing REMS Pharmacy Integration: RAPID – UBC’s Standards-Based Solution That Minimizes Burden while Elevating Compliance and Patient Safety
Pharmacies are essential to REMS—but manual processes and fragmented systems create risk and inefficiency. UBC’s RAPID API offers a secure, standards-based integration that streamlines REMS activities directly within pharmacy workflows. Learn how RAPID reduces burden, improves data quality, and elevates patient safety across the REMS ecosystem.
Is Your Real-World Data ‘Fit-for-Purpose’? The Critical Role of Feasibility Assessments
Designing a database study can be challenging with the proliferation of RWD availability and source diversity. Learn how to ensure that database feasibility assessments successfully identify the most relevant data sources appropriate for the evaluation of study objectives.
Enhancing patient engagement with technology and digital solutions
Patient engagement plays a central role in medication adherence, persistence, and retention. Explore how digital tools, including EHRs, electronic healthcare technology, and digital assistants, can contribute meaningfully to patient engagement.
What Place for Humans in a PV World Integrating AI?
Artificial intelligence is transforming pharmacovigilance—but human expertise remains essential. As AI systems evolve to support drug safety monitoring, ensuring human oversight is key to managing risk, improving outcomes, and maintaining trust. At UBC, we’re blending AI innovation with deep PV knowledge, empowering our teams through AI awareness training and shaping a safer future for patients. Discover how AI and humans can work together to advance pharmacovigilance.
Linking real-world data with commercial patient access programs: A strategy for enhanced insights into factors that impact patient access and adherence to therapy
UBC’s approach to real-world data tokenization and linkage enhances study results with longitudinal observation of various participant health outcomes during the pre-and post-trial period.
Longitudinal Real-World Data: How to Gain Deeper Insights Into Your Clinical Studies
Linking longitudinal real-world data (RWD) to clinical study data offers deeper insights for drug developers. Contextualize study outcomes, extend data collection after the study ends, close the efficacy-effectiveness gap, and identify post-market patterns.
