Case Study

Diagnostic Cancer Study Is Rescued For On Time Premarket Approval (PMA) Filing

Source: PRA Health Sciences

Comparison of the performance of a new in vitro diagnostic test for post-colonoscopy in subjects with colorectal cancer and pre-colonoscopy in subjects from a guideline-eligible screening population.

A molecular diagnostics company with a novel in vitro diagnostic test to detect colorectal cancer requested that PRA help rescue a full-service study crucial to its premarket approval (PMA) filing. The previous CRO had missed site and patient enrollment milestones, potentially jeopardizing the study’s PMA filing and Food and Drug Admin­istration (FDA) approval.