Clinical Operations Unit

As an Investigator site, Gustave Roussy has a Clinical Operations Unit ensuring clinical research activities for all therapeutic trials and clinical studies.  This service is provided regardless of the sponsor category (pharma industries, biotech, scientific associations, academic institutions), at all development phases (from early to advanced phase) including strategic areas such as Molecular Medicine, Antitumor Immunology, DNA repair and rare Cancers.

While under the responsibility of the principal investigator, the unites role is to coordinate all clinical research for adults and children with the various actors (medical doctors, hospitalization units, technical or medico-technical platforms) thus ensuring optimal efficiency and meeting high international quality standards.

As an Investigative center, Gustave Roussy was named “Clinical Research Center” by the French Ministry of Health.  With its established structure for adult and child early phase studies, it was named CLIP2 by the National Institute of Cancer.  The Clinical Operations Unit team includes around 200 professionals (study coordinators, clinical research technicians, medical clinical research assistants, clinical trial assistants, planners, research nurses, sample managers, project managers) dedicated to investigation activity.

The management of more than 700 projects and more than 3,000 new patients per year in Research Involving Humans (RIH) gives Gustave ROUSSY a leading role and contributes significantly to the attractiveness of France for clinical research.

Missions and objectives

• To ensure optimal management of patients participating in clinical research projects for the different departments and multidisciplinary teams of Gustave Roussy
• To deliver a high level of quality in compliance with clinical research policies and regulations and the ISO 90001 certification.
• To monitor performance and the continuous improvement process in keeping with the level of excellence met by the best centers worldwide. 
• Adapt the activity and anticipate the needs of clinical research resources, to ensure the implementation of the institutional strategic plan