friendly link - friendly link - friendly link - friendly link - friendly link - friendly link - friendly link - friendly link - friendly link

Clinical Laboratory Improvement Amendments (CLIA)

Local labs and Central labs in Clinical Trials

Several clinical trials require specific lab tests. Depending on the study protocol the lab tests are required to establish inclusion and exclusion criteria, monitor the safety of the patients enrolled in the study or demonstrate the efficacy of the investigational product (IP). The sponsor/CRO has two options for gathering clinical…