Sara Schmidt is the Chief Quality & Compliance Officer at Profound Research, where she leads quality and compliance strategy across a growing clinical trial site network. With more than 20 years of experience spanning Sponsor, CRO, and site environments, Sara is passionate about building quality systems that are not only inspection-ready, but also practical and sustainable for teams working on the front lines of research.
Sara brings deep expertise in Good Clinical Practice (GCP), FDA and global regulatory inspections, audit readiness, and data integrity. She has supported and led organizations through successful regulatory inspections and sponsor audits worldwide, helping teams navigate complex requirements with clarity and confidence. Her approach focuses on proactive risk management, early identification of issues, and creating processes that truly work in day-to-day operations.
At Profound, Sara partners closely with site teams and leadership to embed a culture of quality, ensuring that quality is integrated into everyday workflows. She is known for translating regulatory expectations into clear, actionable practices that teams can realistically implement and maintain.
Sara is a Registered Quality Assurance Professional in GCP (RQAP-GCP) and holds a certification in healthcare research compliance (CHRC). She brings a practical, site-focused perspective on inspection readiness and how to confidently prepare for and respond to regulatory inspections in today’s evolving clinical research environment.
