Insights
Insights From Our Experts
Articles
Redefining the QA Role in the Age of AI
Artificial intelligence is rapidly transforming Quality Management Systems, from automating document reviews to supporting inspection readiness and risk prediction. While these innovations bring speed and scale, they also introduce new questions around oversight, accountability, and regulatory…
SIUU vs. Unsolicited Off‑Label Requests: A Practical Comparison
As FDA regulatory expectations evolve, distinguishing between SIUU and unsolicited scientific requests is essential. This quick‑reference chart highlights the key differences between these two regulatory pathways (evidence standards, communication pathways, documentation requirements, etc.) so field teams…
The Integrated Advantage: What Medical Affairs Needs Right Now
A New Reality for Medical Affairs Medical Affairs teams are being asked to do more, faster and with fewer resources, amid growing scientific complexity and regulatory scrutiny. The organizations pulling ahead aren’t layering on more vendors or disconnected solutions, they’re adopting an integrated…
Solving The Rare Disease Launch Paradox — Using Pre‑Launch Planning and Partnership to Create Value
Rare disease patients cannot wait – and neither can the companies working to serve them. For emerging biopharma preparing to launch, the stakes have never been higher. Capital constraints, evolving regulatory timelines, and rising expectations from boards and investors are heightening complexity. These pressures intensify in rare disease, where…
EVERSANA’s AI Agency Platform Wins 2026 AI Excellence Award
This is the 5th Consecutive Year EVERSANA Has Been Recognized by the Business Intelligence Group for AI Innovation EVERSANA has been honored with a 2026 Artificial Intelligence Excellence Award, recognized in the Agentic AI category for our best-in-class AI Agency Platform: our end‑to‑end, enterprise‑grade…
It’s Time for Commercialization to Catch Up to Innovation in Women’s Health
The investment landscape for women’s health is finally shifting. After years of chronic underfunding, capital is surging into the category, signaling a decisive market recognition that advancing women’s health is both an unmet need and a…
4th Annual Brand Planning Report: Fueling Brand Plan Success Through AI‑Powered Integration
Cross‑functional integration and data‑driven strategy remain top priorities for brand leaders, but for many organizations, they’re still difficult to achieve. In our fourth annual report, Chief Strategy Officer at EVERSANA INTOUCH, John Kenny, and Senior Partner of EVERSANA MANAGEMENT CONSULTING, Sean Rapson, explore the state of brand…
Why Women’s Health Is at an Inflection Point and Why Commercialization Must Catch Up
Women’s health is undergoing a long‑overdue transformation. After decades of chronic underfunding, investment in women’s health has accelerated dramatically with capital surging more than 300% in 2018 and then tripling again between 2019 and 2024. Innovation…
Webinar Recording | From MFPs to MFN: Navigating the New Rules of Drug Pricing in 2026
In this recent webinar, experts John Neal, Katya Svoboda, and David Byram examine the major policy shifts transforming the U.S. drug pricing landscape—including the accelerating impact of MFN models, evolving MFPs, PBM transparency reforms, and the…
Gartner Is Right — About the Wrong Kind of Agency AI Platform
Gartner’s warning isn’t anti‑AI—it’s anti‑dependency. The distinction will define which agencies remain relevant by the end of the decade. A recent Gartner study predicts open-source platforms will support more than 75% of enterprise AI deployments by 2028, and their concern about CMOs getting locked…