Insights from
UBC's Expert Voices

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.

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 […]

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.

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 […]

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.

Rescue studies are a challenge, and often enrollment is a top reason for switching. But mismatched partnerships go beyond enrollment.

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.

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.

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.