Clinical research is a branch of health sciences that determines the safety and efficacy of drugs, medical devices, and other products intended for human use, which are used for the prevention, treatment, diagnosis, or alleviation of symptoms of a disease.
Clinical studies are conducted with healthy volunteers or patient volunteers, in all cases, they must be conducted in compliance with the standards of good clinical practice and the principles of the Declaration of Helsinki, respecting the autonomy and freedom of the participants.
Prior to commencing clinical trials in humans, we must have conducted the relevant studies in animals and in vitro models, demonstrating that our product meets the necessary requirements to minimize risk as far as possible.
Once we have the complete preclinical safety package, as well as the necessary proof-of-concept studies, and we have certified the manufacture of our product in accordance with the applicable regulations (GMP or other international standards, depending on the type of product), we must submit the investigational product dossier to the relevant regulatory agency.
At Kinrel, we have extensive experience in the management of preclinical and clinical studies, so we can advise and accompany you in the preparation of the necessary documentation to start clinical trials, as well as in their subsequent management and monitoring.