Real-World Evidence in EU Joint Clinical Assessments: Strategic Use and Methodological Standards
With immature survival data, single-arm trials, and limited comparators common in early JCA submissions, real-world evidence is becoming a strategic necessity, not an afterthought. Learn how sponsors can plan and generate RWE that meets the methodological bar EU assessors expect.
From Approval to Access: Adopting a “One Evidence Package” Mindset for Success in the EU Joint Clinical Assessment Era
The EU Joint Clinical Assessment is driving a new approach to evidence generation, where regulatory approval and market access considerations must be addressed together. Drawing on lessons from the first completed and discontinued JCA cases, this article explores how integrated evidence planning, comparative effectiveness evidence, proactive PICO management, and strategic use of real-world evidence can help organizations navigate evolving European requirements and support successful reimbursement and patient access outcomes.
Navigating the AI Landscape: Expanding the Toolbox (Part 2) and Having a Little Fun Along the Way
AI can support much more than drafting content. In Part 2 of our series, we explore practical tools that help teams organize information, improve communication, capture meeting insights, visualize complex concepts, and work more efficiently so experts can stay focused on what matters most.
Why 95% Compliance Isn’t Enough: The Hidden Cost of That 4–5% Gap
A 95% compliance rate sounds strong, until you calculate what it means at 100,000 cases a year. Here’s what’s actually hiding in that gap, and the four questions every sponsor should ask before signing with a PV vendor.
The Centaur Model: What the Future of Pharmacovigilance Actually Looks Like
AI isn’t replacing pharmacovigilance professionals. It’s changing how they work. Learn why the centaur model, where humans direct AI rather than defer to it, is emerging as the standard for regulated safety operations.
The True Cost of Cheap PV: A Framework for Evaluating Your Options
AI savings numbers are easy to put in a proposal. What’s harder to find is what happens when something goes wrong. Here’s a framework for pricing in the risk that vendor pitches leave out, plus four questions worth asking before you switch.
Five Ways AI is Already Changing Case Processing and Where Humans are Still Needed
From triage to causality assessment, AI is changing how case processing teams work. We break down five areas where automation is making an impact, and the human expertise that still has to anchor every decision.
Novel Treatments for Mental Health and Considerations for Risk Management
Psychedelic-assisted therapies are emerging as a promising frontier for treatment-resistant mental health conditions. As the regulatory landscape evolves, robust risk management frameworks will be critical to bringing these therapies safely to patients. UBC explores the current landscape and what approval pathways may mean for sponsors.
The AI vs. Automation Question Nobody in PV Is Asking Clearly
Automation and AI are often used interchangeably in PV, but they’re built for different jobs. This piece breaks down where each one delivers value, and how to choose the right fit without adding unnecessary complexity.
