KCRI has a comprehensive experience in successful registration, execution and submission of First In Man (FIM, also known as First In Human, FIH) clinical studies of high risk medical devices. First In Man (FIM) studies are very peculiar and sensitive in nature due to their early exploratory character and the first-ever attempt to test a medical product in patients. As such, they require very stringent ethical and medical oversight, investigators and sites with a lot of experience, and extremely hands-on, individualized research support and care.
We frequently partner start ups and large manufacturers with transition from non-clinical to clinical research, helping to establish adequate safety measures and navigate through regulatory requirements for these phase I studies, all the while ensuring superior patient safety.
ISO 9001 quality management certification of KCRI specifically includes management of early medical device studies (FIM).