1 Regulatory Authority (ANSM) & 1 Central Ethic Committee (CPP)
Unique agreement template for all hospitals (Fully Executed in 45 days)
Pilot Phase : in preparation of EU Clinical Trials regulation
Fast-Track Processes : accelerated authorizations for Investigational Products
More than 30 years experience for Temporary Authorization for Use (TAU) for innovative not marketed drugs
EUCROF leader for EU Code of Conduct design with CNIL (French Data Protection Authority) as reference body
Research Tax Credit = 30% for R&D
Operational excellence
AFCROs is the largest member of EUCROF with 90 French companies
Health Data Hub: Unique Public Database about French health data
Active academic network (F-CRIN) and Public structures (CNCR) to enforce & coordinate Clinical Research
Fully trained professional by recognized courses; Internationally specialized courses (Pharmaco-epidemiology, Real World Data)
Medical excellence
Several scientific academic societies
International reputation of our KOLs
Large patient advocacy groups led by experts patients
Oncology & Rare Disease: top French expertise
Oncology
45% of French Industrial Trials (versus 25% in Europe)
16 labelled centres for cancer early-phase (INCa-CLIP)
Unique Oncology Network (public or private centers) such as « Centre de Lutte contre le Cancer », Institut Gustave Roussy…
Rare Disease
8 out of 24 European Reference Network for addressing patient to specialized centre
109 expertise centres for diagnostic and treatment of rare disease+ Public and Private commitment in Rare Diseases research: 3rd French governmental plan for 2018-22