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.
Reality Check: AI in Pharmacovigilance Is Not What We Think
AI is everywhere in PV conversations, but far less mature in practice. Here’s what stood out from Why Summit: Future of PV: validation bottlenecks, signal inflation, and why the real challenge isn’t technology.
Key Insights from the 2026 REMS Industry Consortium Annual Meeting
AI, standardization, and a shifting FDA landscape. Here’s what the 2026 RIC Annual Meeting revealed about the future of REMS.
How North American Privacy Frameworks Shape Real-World Evidence: A Comparison of Canada and the United States
Canada’s consent-driven data silos and the U.S.’s regulatory patchwork aren’t just administrative hurdles — they’re determinants of bias in real-world evidence.
EU Post-Marketing Compliance: What Regulation 2025/1466 Means for Your Pharmacovigilance Program
Implementing Regulation (EU) 2025/1466 is in full effect — and it’s the biggest change to EU pharmacovigilance rules in over a decade. Here’s what your compliance team needs to act on right now.
Access USA 2026: Key Takeaways on AI, Affordability, and Patient Support
Two phrases defined this year’s Access USA conference: “calm the chaos” and “can’t eliminate the human touch.” As AI reshapes patient support programs, the question isn’t whether to adopt it, but how to deploy it without losing what patients value most.
