Amy Karels is the Quality Assurance Director at AXIS Clinicals LLC, bringing more than 26 years of experience in clinical research. She has spent 15 years in clinical operations, working across a diverse range of clinical studies and projects, which provides her with a deep, practical understanding of clinical trial conduct from both operational and quality perspectives. Throughout her career, Amy has been actively involved in sponsor qualification visits, regulatory authority inspections, and responses to regulatory queries, including interactions with the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO), and regulatory authorities in Thailand and Malaysia. Her regulatory experience supports AXIS Clinicals’ commitment to inspection-readiness and global compliance. In her current role, Amy leads continuous improvement initiatives, with a strong focus on Corrective and Preventive Action (CAPA) management, risk mitigation, and quality systems enhancement. She is dedicated to ensuring compliance with ICH guidelines and FDA Good Clinical Practice (GCP) requirements, while promoting a culture of quality, accountability, and operational excellence.