Leading Clinical Research provides all of the services needed for clinical investigations of medical devices, whether the study aims at obtaining the CE marking or forms part of post-marketing surveillance.
There is a widespread misconception that there is no real difference between medical device and pharmaceutical studies. LCR knows the variances between these different types of studies and is able to provide you with specific services in compliance with effective directives, ISO and local regulations.
All of our Clinical Research Associates (CRAs) are trained in ISO 14155. Highly experienced and qualified clinical staff is able to assist you with your pre- and post-marketing studies:
Leading Clinical Research has also a certified Quality Management System compliant with the ISO 9001:2008 standard for the conduct and organization of clinical investigations.
One of the clinical investigations run by LCR was recently inspected by the local regulatory authority. We are proud that the inspection was without any finding!