Product/Service

In-Vitro Diagnostic Device Clinical Trials

Source: LabCorp Clinical Trials

LabCorp Clinical Trials provides full-service central laboratory services in support of 510(k) and PMA clinical trials for in vitro diagnostics (IVD). We have extensive experience working with diagnostic companies to bring new tests to market by combining our broad-based laboratory capabilities with expert project management, data management and regulatory insight developed from working over 20 years on thousands of clinical trials across all major therapeutic areas.

We can seamlessly develop, validate and conduct IVD trials, as well as commercialize new assays including companion diagnostics.

Services include:

  • Conduct studies to compare an investigational device to an approved or cleared predicate device
  • Assist with IRB approval and specimen acquisition strategies
  • Perform reproducibility studies conducted at one or more sites within the LabCorp network
  • Pre-trial evaluations by scientific experts familiar with similar devices
  • Conduct diagnostic clinical studies to comply with all applicable regulations