EXPERTISES

 

Health Products (drugs/ DM / IVD MD )

RCTs supports the pharmaceutical firms and medical device companies

 

With over 30 years of experience, RCTs guides you in all phases of clinical development of your health products (drugs, medical devices, in vitro diagnostic medical devices) in most therapeutic areas..

Depending on your needs, RCTs provides overall management of your study (from study design to clinical report) or a specific service (monitoring, data-management, biostatistics) in France and abroad, and in compliance with current regulations (Public Health Code, ICH GCP, ISO14155, MEDDEV, RGPD, etc.) and our quality assurance processes.

Whether you are a Company or institutional Sponsor, we will carry out for you phases I to phase IV clinical trials and will support you in the entry into force of regulation No. 536/2014 regarding clinical trials of drugs for human use.

RCTs has also developed a real expertise in the evaluation of medical devices.

You are a medical devices manufacturer and wish to be supported by a professional, contact RCTs, whether for consulting or for your pre or post CE marking assessments. We will study your medical device specificity and will guide you particularly in the compliance with the UE 2017/745 European regulation.

Drug

Medical Device

IoT

Telemedicine

We have already accompanied them

CE marking of DBLG1 ™, the innovative technological solution that integrates artificial intelligence

Our experts are available for you

Morgane Champiot
Study Director - Member of the AFCROs MD working group
Frédéric Mistretta
General Manager - Head of Biometry - Co-pilot of the AFCROs’ Real World Data working group
Dr Jean-Sylvain Larguier
General Manager - Medical Director - MD-PhD and former co-pilot of the AFCROs’ MD working group

Next expertise

ATU / RTU Learn more

Do you need a strong
partner to rely on ?

 

Let’s talk about it