Challenge: A growing in vitro diagnostics company needed regulatory and clinical trial assistance for a 510(k) submission and a CLIA waiver.

Beaufort Solution: The company’s previous interactions with FDA highlighted a need for assistance in finalizing its clinical trial protocol, subsequent clinical trial management, and preparing for a pre-IDE meeting with FDA.  Beaufort developed a comprehensive clinical trial protocol that provided the statistical power to support the intended uses. Beaufort prepared the company for interactions with FDA and meetings with the agency.  Following these meetings, FDA supported the clinical plan which enabled the trials to move ahead and Beaufort located, qualified, and coordinated clinical trial sites for a highly time-sensitive trial.

Date posted: October 27, 2011

Categories: Case Studies Clinical Research Regulatory Affairs