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Centaur Clinical is a Contract Research Organization specialized in the pre-clinical testing and clinical trials for medical devices

Preclinical testing

With its 140m2 laboratory, Centaur Clinical is capable of conducting preclinical testing in accordance with ISO-10993 and Good Lab Practice.

Clinical trials

Centaur Clinical’s expertise is in the field of Clinical Operations, and thus we can take care of your clinical trial projects, from the early stage design to the post market phase, in accordance with ISO 14155 and Good Clinical Practice.

Regulatory Writing

Using the current regulatory processes, such as EU Medical Device Directive (MEDDEV) 2.7 rev 4 and EU law 2017/745, Centaur Clinical writes up and prepare the documents necessary for the submission to the regulatory or notified bodies.

A multilingual team will provide you a dedicated and optimal support.

Centaur Clinical helps manufacturers with the CE marking of the medical devices, including diagnostics, from the pre-clinical to the clinical trial stage and to the post-market phase.

Thanks to the team’s experience in various type of devices and therapeutical areas, particularly in oncology, cardiology and ICU studies, Centaur Clinical can provide an unrivalled expertise. Centaur Clinical also has a network of partners to help you with areas such as Data Management, Biostatistics, Clinical Operation in other continents, according to your needs.

Quality

Centaur Clinical has a Quality Management System in place to ensure that we are audit and inspection ready. We follow the ISO 13485:2016 process and stride to get certified in the upcoming months. Thus we know exactly what the manufacturer is dealing with in terms of regulatory obligations.

Centaur Clinical services are in accordance with GCP, ISO 14155 and the regulations in place.