What is a contract research organization (CRO)?
Contract research organizations (CROs) provide support in clinical (and also analytical) studies and perform tasks for the sponsor of the respective study. They are involved in the management, monitoring and conduction of studies and can function as study site.
An IVD contract research organization provides specialized support to the IVD industry. Regulatory requirements differ from the pharmaceutical counterpart. Thus, specific services are implemented to support IVD-manufacturers during all IVD life cycle phases. For example, requirements of the IVDR and ISO20916 are within the scope of a clinical performance study for IVD. The necessary processes, standards and templates are in place, the employees are trained and experienced in collecting clinical / analytical data for IVDs.
Importantly, if a sponsor commissions a CRO, the sponsor remains obliged to monitor the external organization and is ultimately responsible for the quality and integrity of the study (see also ISO20916 section 5.1).
