How well a study is conducted determines whether the application for market approval of the new device is successful. Thus, it is crucial to know the appropriate processes to utilize while conducting in vitro diagnostic product, or IVD, clinical trials to ensure compliance with regulatory requirements. This session explores the technical and logistical considerations critical to conducting IVD studies and helps you assess the factors that impact the generation of quality data.
Outline the technical and logistical considerations that are critical to conducting IVD studies
Discuss the sponsor perspective from investigational device production to study execution
Discuss the site perspective from execution to study close-out