Established in 2001 the CIC 0202 is positioned on therapeutic antibodies. Accordingly, its three components are part of studies carried out on monoclonal antibodies:
- Clinical Investigation: the premises, medical and nursing staff are involved in the implementation of clinical protocols either on patients or healthy volunteers. The CIC counts 1 Hospital Practitioner, 3 state registered nurses (soon 4 with the opening of an antenna in the Trousseau hospital site) and 2 Technician’s. Four investigation beds are fully dedicated to research. Finally, in addition to dedicated premises, staff are required to move around the healthcare services when patients cannot come to the CIC premises. Of the 35 studies managed in clinical investigation in 2009 six were part of the mAb theme (3 in rheumatology, 1 in nephrology, 1 in hematology and 1 in oncology).
- Insurance and Quality Control: carrying out studies sponsored by the University Hospital of Tours: the team includes a project manager and 8 QA inspector’s in charge of the administrative-regulatory aspects of the studies promoted by the University Hospital of Tours. In addition, the QA inspector organizes study logistics at the centers by establishing ad hoc circuits, mainly for biological samples. Links with the CRB are narrow: each study of sampling management with preservation is organized in partnership with the CRB.
- Methodology and Biostatistics: preliminary (development of protocols, editing files…) and further work (management and data analysis). The team includes a Biostatistician Professor-Hospital Practitioner (MCU-PH), a University hospital assistant (AHU), 3 biostatisticians and 2 data managers. This biometrics unit is involved in most clinical research projects promoted by Tours University hospital with close co-operation from the planning stage of the study up to data analysis and their interpretation. Note that the head of the biometry unit is also inter-regional manager of the biostatistics methodology network of the DiRC Grand Ouest. In this context, they coordinated the acquisition of the Capture System software, which enables the development of electronic books. This software is shared between the six Grand Ouest University hospitals and soon with the 3 Grand Ouest Centers for the fight against Cancer (CLCC).