IVD products
In vitro diagnostics
At Scandinavian CRO, we can support you in conducting clinical performance studies, performance evaluations, or developing a clinical development strategy for your in vitro diagnostic.
Confirming the safety and performance of
your in vitro diagnostic
In vitro diagnostic medical devices require a strategic approach to ensure that there is sufficient clinical evidence to confirm the safety and performance of your in vitro diagnostic for its intended use. Scandinavian CRO has extensive experience with pre-market clinical performance studies, performance evaluations, and post-market performance follow-up activities, as well as helping sponsors to develop a clear path for the development of their in vitro diagnostic.
SCRO services for in vitro diagnostics
Pre-CE clinical performance studies
The purpose of clinical performance studies is to establish or confirm aspects of in vitro diagnostic device performance that cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. The data from clinical performance studies are used in the performance evaluation to demonstrate compliance with the relevant safety and performance requirements with respect to the clinical performance of the in vitro diagnostic.
Performance evaluations
Performance evaluation is the process of collecting and assessing all clinical data relating to the in vitro diagnostic in order to evaluate whether there is sufficient clinical evidence that demonstrates that the in vitro diagnostic conforms to the relevant regulatory requirements. The performance evaluation process and its results are documented in a performance evaluation report (PER), which confirms that the in vitro diagnostic is ready for market use. In addition to this, the report is continually updated during the product’s lifecycle.
Post-market surveillance
After the in vitro diagnostics is marketed, the sponsor is responsible for continuing to collect clinical evidence regarding the in vitro diagnostic’s clinical safety and performance (i.e., post-market surveillance or PMS). The PMS plan includes activities such as vigilance and post-market performance follow-up (PMPF).
