Prevention strategies and best practices
Implement proactive strategies that prevent common deficiencies, including workflow design, training approaches, and quality oversight systems.
The morning the culture changed
Dr. Rachel Thornton remembers the exact moment she decided to rebuild her organization's approach to TMF quality. It was a Thursday afternoon in October, in a windowless conference room at Northbrook Clinical Research Institute in Columbus, Ohio. She was reviewing the findings from their third FDA inspection in five years, and for the third time, the findings centered on documentation deficiencies that should never have occurred.