Ron Fitzmartin, PhD, MBA
Ron Fitzmartin, PhD, MBA, is a regulatory science and drug development leader with 25+ years of experience advancing regulatory policy, data standards, and modern submission processes across government and industry. He is known for building multidisciplinary teams and delivering complex initiatives that improve data quality, interoperability, and regulatory decision-making.
He is the Principal Consultant at Decision Analytics, LLC, where he advises regulators, global health partners, and industry on implementing global data standards, streamlining submissions, and improving end-to-end data governance. His recent work includes benchmarking and evaluating generative AI tools for regulatory use, using practical performance metrics and blinded comparisons to assess reliability, consistency, and fitness for real-world regulatory workflows.
From 2012 to 2025, Ron served at the U.S. Food and Drug Administration as a Senior Informatics Advisor in both CDER and CBER. He led key standardized study data policy initiatives, supported FDA’s work on IDMP guidance and global implementation, and held leadership roles in ICH, including regulatory chair for the ICH M8 Electronic Submissions EWG and rapporteur for the ICH M11 Clinical Protocol Template EWG.