Clinical Research Center

• Assistance with assessing the feasibility of studies;
• Assistance in setting up the study;
• Assistance in the care of volunteers or patients (information on trial procedures and the conduct of visits, signing of consent, evaluation questionnaires, patient booklet, use of treatment, etc.);
• Managing the schedules of visits and examinations of volunteers or patients according to the protocol;
• Performing nursing procedures: taking vital signs, drawing blood, administering treatments…
• Management of study equipment (receipt of laboratory kit, preparation of samples, management of sending of samples, etc.);
• Working in collaboration with the sponsor's CRAs and the investigator CRAs of the care service;
• filling in observation notebooks;
• assistance with closing and archiving.

These tasks are à la carte and must be defined before the study is implemented.

All hospital departments can call upon the Clinical Research Centre to conduct studies in any type of pathology, concerning drugs and medical devices.

The CRC team provides medical and/or logistical support to investigators for the conduct of their study.

Studies can be carried out on the CRC premises or “off-site” with the provision of CRC staff.

A clinical trial is structured in 4 phases:

-Phase I trials are the first-time administration trials of the drug in humans. The objective of this first stage is to evaluate the safety of the drug, to determine the dose and frequency of administration to be recommended for subsequent phases, as well as the fate of the drug in the body.

-Phase II trials allow us to evaluate the efficacy and tolerability of the drug and to determine its optimal dose.

Phase III trials are generally comparative trials that allow for the evaluation of the superiority of the new treatment's efficacy by comparing it with the treatment usually used or with a placebo

-Phase IV trials take place after obtaining marketing authorization and marketing of the drug.

When a patient is offered the opportunity to participate in a clinical trial, their participation corresponds only to a specific phase (I, II, III or IV) of the drug's development and in no case to its entirety.

Clinical trials are essential to advance scientific knowledge but also to improve disease management and patient care pathways.

In France, clinical trials are highly regulated. Current legislation ensures respect for patient rights, interests, and safety.

It has been authorized by the Regional Health Agency (ARS) since its creation in 2007 to conduct early-phase trials and trials on healthy volunteers. It has been accredited by the Directorate General for Healthcare Provision ( DGOS) .

Located on the 13th ^floor of the Côte de Nacre tower , the premises are secure and authorized to receive healthy volunteers and patients for biomedical research in adults. The CRC is also authorized to conduct early-phase studies.

The service operates in day or continuous hospitalization according to the protocols and includes in particular 5 hospitalization beds distributed in 3 rooms, a sampling room, a room for preparing and freezing biological samples with appropriate equipment.

Located on the ^1st floor of the South building , it has also been authorized by the ARS since June 2020 to receive infants or children in the context of biomedical research, particularly in the early phase.

The service operates in day hospitalization or continuous hospitalization according to the modalities of the protocols and includes 1 clinical research office, 1 hospitalization bed, a room for the preparation and freezing of biological samples with the appropriate equipment.