Kaitlyn Enright, PhD
Regulatory & Clinical
Dr. Kaitlyn M. Enright is a regulatory and clinical research leader who has spent more than 15 years directing high-stakes clinical programs and regulatory submissions at the intersection of science, compliance, and AI. She has overseen 60+ studies across 24 countries spanning drugs, medical devices, Software as a Medical Device (SaMD), and AI-enabled health technologies.
A Certified Principal Investigator (ACRP-CPI) and author of more than 40 peer-reviewed publications (h-index 11), Dr. Enright is known for translating complex scientific and regulatory requirements into audit-ready deliverables. Her submission experience spans FDA, EMA, Health Canada, EU MDR, and ICH-GCP frameworks, with particular depth in structured authoring for modular regulatory dossiers.
As AI adoption accelerates in healthcare, Dr. Enright has become a recognized expert in clinical AI governance — developing human-in-the-loop quality models for AI-assisted regulatory documentation and advising on the evidence-generation requirements that regulators expect for AI-enabled health products. She helps organizations navigate evolving FDA and EU AI Act guidance for medical AI systems, building compliance programs that hold up under audit.
At DataStudios, Dr. Enright works with life sciences and healthcare technology clients to design AI governance frameworks, clinical evidence strategies, and regulatory submission programs that meet the emerging standards for AI in clinical settings.