- GenDx can support your therapy development in any stage, during the pre-clinical stage with RUO reagents and during the clinical stages, from first in human to the pivotal registrational trial. At the moment, that clinical device studies are required, GenDx can support interventional clinical studies (both prospective and retrospective) and clinical bridging studies.
- As IVD sponsor of the clinical study we facilitate performance study applications to the regulatory authorities and ethical bodies and we ensure clinical monitoring of the clinical testing site, through our strong network of partners.
