Gustave Roussy Clinical Research Division
Gustave Roussy clinical research division is relying on a board to implement the clinical research strategy, to coordinate activities, to bring the projects into operation and to supervise the centralized clinical research platform.
Labeled DRCI (“Délégation à la Recherche Clinique et à l'Innovation”) by the Ministry of Health, it is part of GIRCI Ile-de-France (“Groupement Inter-Régional de Recherche Clinique et d'innovation ») whose aims are training and information for clinical research professionals and support in the response to calls for European projects.
Gustave Roussy clinical research is organized in 5 offices in order to support the ambitions of the Institute in terms of clinical research, to be readable by all partners, to facilitate projects implementation, execution and valuation, and to meet high international quality standards :
- The Projects and Sponsorship Office, which includes all clinical research activities for studies promoted by Gustave Roussy, set-up activities for studies conducted at Gustave Roussy as investigator site and all finance and contract aspects
- The Biostatistics and Epidemiology Office, labelled "Center for Data Handling" by the National Cancer Institute (INCa) since 2007, ensures the design of study’s methodology, data management, data analysis and results publication. The Office develops research in methodology and statistics for genomics, early phase trials and meta-analysis too.
- The Clinical Operations Unit, labelled Clinical Research Center by the Ministry of Health, which includes all clinical research activities (from initiation to close-out) for all the studies (early or advanced phase) conducted at Gustave Roussy as investigator site.
- The Quality Office, which ensures the information and implementation of Regulations, the homogenization and dissemination of rules/procedures, the preparation of audits and inspections, the organization of the ISO9001 certification at the clinical research division level. It also ensures the GCP training, the support to the Committees and the monitoring of quality with the Heads of the departments collaborating with clinical research. The Quality Office includes the Pharmacovigilance Unit, which manages the pharmacovigilance of all the studies promoted by Gustave Roussy and which develops a research program in pharmacovigilance.
- The Valorization Office, which supports data dissemination, optimizes the clinical and biological data use and promotes the synergy with the translational research.