Guest Column | May 7, 2026

Aligning AI Use Clinical Trials With FDA And EMA Expectations

By Jessica Cordes, senior consultant, Clinical Excellence GmbH

Even when strategic decisions, vendors, and data science teams sit in the United States, the moment a clinical trial is conducted in EU/EEA countries, European regulators will expect the sponsor to demonstrate that any AI used across clinical trial planning, conduct, and analysis is transparent, controlled, and fit for purpose within the European regulatory context. The recent publication of the EMA’s Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle¹ marks a critical milestone for anyone involved in clinical development, especially U.S.-based sponsors who plan or already conduct clinical trials in Europe.

Please read the full Clinical Leader Article.