Clinical Research: Phase 1 - Phase 4

A 7-Step Roadmap for Operationalizing Large‑Scale Clinical Validation Studies

Liquid biopsy tests represent both a promising alternative to existing screening methods and an opportunity to develop cancer detection tests for indications where no such screening method is yet available. Given the risk associated with both false positives and false negatives, liquid biopsies intended for screening and early cancer detection are subject to a high level of regulatory scrutiny. Generally, in vitro diagnostics (IVDs) of this nature must follow the pre-market approval (PMA) pathway and require large-scale validation studies, which can be an expensive undertaking and operationally challenging to execute. This is where Premier Research can help.

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