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