Quality Office
Gustave Roussy clinical research is organized to enhance its performance, to develop its ability to manage large national and international academic trials with high added value and to strengthen Gustave Roussy position as a preferred innovative trials platform for pharma companies.
To gather in a single office all quality assurance activities in clinical research both for studies sponsored by Gustave Roussy and for studies conducted at Gustave Roussy as investigator site provides an organization easily readable by all external and internal partners and facilitates projects implementation...
In a very competitive national and international environment for clinical research, this organization provides Gustave Roussy the ability to maintain and increase its efficiency, quality and its attractiveness to become a major actor in oncology clinical research, meeting the high international quality standards.
The main purposes of this Quality Office are the following:
- To keep a regulatory watch on GCPs, and inform departements/offices concerned of any regulatory changes
- To ensure processes harmonization and rules / procedures dissemination
- To ensure organization of the GCPs training for the clinical research team and for health care professionals
- To ensure the audits / inspections preparation, coordination and reporting
- To be the quality representative of the clinical research division for the Quality division
- To ensure the organization of the ISO9001 certification within the clinical research division
A close collaboration with the other Offices, with the Committees by participating in their assessment and with Gustave Roussy Departments, is key to enhance and to maintain in order to support them for the quality approach in their daily activities.
