Drug Repurposing in Rare Diseases: The Impact of Natural History Studies
Drug repurposing is transforming the landscape of rare disease treatment by leveraging existing medications for new uses. With significantly lower development costs and faster timelines, this approach is gaining traction—especially when supported by natural history studies that provide deep insights into disease progression and real-world treatment patterns.
EMA Issues Guidance on Risk Minimisation Measures for Medicinal Products with Embryo-Foetal Risks
The EMA’s August 2025 guidance on embryo-foetal risk minimisation marks a pivotal step in harmonizing safety protocols across the EU. This blog breaks down the new Addendum I to GVP Module XVI, clarifying what constitutes a Pregnancy Prevention Programme and how risk minimisation tools can be effectively implemented without compromising patient access to essential treatments.
To Rescue or Not to Rescue Your Study: How to Spot Trigger Points in Strategic Partnerships
Instability is woven into our industry’s DNA. We operate daily in a high-stakes, high-risk environment where financial pressures, regulatory changes, and patient lives hang in the balance. The CRO selection process reflects this tension, few other sectors require competitors to both challenge and collaborate with one another, often for the same client. Our ecosystem is […]
The Critical Role of the QPPV: Insights from UBC’s Pharmacovigilance Experts
In this expert interview, UBC’s Tom Coles and Peter Psarologos dive into the essential role of the QPPV in EU pharmacovigilance. From legal requirements to strategic value across the product lifecycle, discover how UBC helps clients stay compliant, inspection-ready, and focused on patient safety.
Evidence Matters: Joel White of Marketcap Consultants
Recently, Aaron Berger, SVP of Evidence Development Solutions, had a chance to sit down and talk with Joel White of Marketcap consultants, to discuss the state of life science trends and the next wave of real world evidence generation. Joel has long been an important voice in the life sciences space, always with his finger […]
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.
