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.
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