Automated ECOAs That Reduce Risk and Improve Data Quality with Elan Josielewski & Anthony Mikulaschek of IQVIA

Clinical trials often slow down at the exact points where precision is most critical — manual coding steps, fragmented workflows, and regulatory processes that introduce avoidable risk. In this episode, Elan Josielewski, Senior Director of Patient Centered Solutions at IQVIA, and Tony Mikulaschek, Vice President of eCOA at IQVIA, discuss how connected automation removes these failure points across the ECOA lifecycle. They outline how pre‑validated digital instrument libraries replace months of manual coding with audit‑ready configurations, how automated documentation now covers more than 70% of study requirements, and how automated screenshot generation can produce tens of thousands of localized IRB‑ready pages in under an hour. The conversation focuses on how these capabilities strengthen measurement integrity across global sites while reducing operational risk throughout long, complex trials. Want to share your AI adoption story with executive peers? Click emerj.com/ex2 for more information and to be a potential future guest on Emerj's flagship 'AI in Business' podcast!