Challenge: A molecular diagnostics company developing proprietary nanotechnology to enable earlier detection and treatment of disease needed assistance conducting clinical trials in support of a 510(k) submission to FDA.

Beaufort Solution: Beaufort provided clinical trial management support, including clinical trial and regulatory document preparation, IRB submissions, and clinical trial monitoring support.  This support enabled the company to make its first successful 510(k) submission to FDA.

Date posted: October 27, 2011

Categories: Case Studies Clinical Research