An IVD clinical performance study evaluates whether an in vitro diagnostic test performs as intended in the target population and clinical setting. For FDA, IVDR, and global regulatory planning, sponsors should be prepared to generate evidence around intended use, analytical performance,…
How to Choose the Right Diagnostic CRO for FDA-Ready Clinical Studies
Choosing a CRO Built for Diagnostic Clinical Studies A diagnostic CRO should understand that diagnostic studies are not the same as drug trials. The right diagnostic clinical trial CRO should help sponsors design FDA-ready protocols, select appropriate sites, manage comparator testing,…