InnPROGRESS Platform
Early Clinical Trials Platform
Heads:
Pr. Benjamin Besse; Guylène Chartier; Thibault Raoult
Objectives
Access to key opinion leaders and a broad range of services to support the development of clinical trials, with the option to sponsor studies in accordance with the institute’s internal processes.
Operator (s)
Technology and expertises
The Clinical Research Division is nationally and internationally renowned. It comprises a team of experts including senior clinical research physicians, project managers, pharmacists, statisticians, regulatory affairs managers, pharmacovigilance experts, data managers and clinical research associates.
Services and activities
Start-up: Identification of key objectives and implementation needs.
Coordination: Connection with clinical research experts (CREs).
Synopsis: Support in drafting the study synopsis by CREs.
Protocol: Support in developing the clinical trial protocol by CREs.
Product: Access to medical and paramedical experts for guidance on drug and medical device use.
Platform: Connection with Gustave Roussy technology platforms for downstream analyses.
Budget: Support in setting up the clinical study budget.
IMPD: Support in preparing the Investigational Medicinal Product Dossier.
Investigator: Support in identifying expert investigator centers.
Review: Expert review of study documents by CREs.
Practice: Guidance on the operational feasibility of the clinical project.