Preparation and review of complete files before submissions

  Ø Afssaps :

             o   Demand for registration number (for medical devices) or Eudract number (for drugs)

             o   Clinical Research authorization demand           

             o   Form for amendments

             o   Public directory of clinical trials approved

  Ø CPP :

             o   Mail and form for opinion demand

             o   Additional documents

             o   Review of Informed consents

  Ø CNOM : Opinion demand to the National Council of Medicine for financial contracts of

                  investigators and experts involved in trials in France

  Ø DMOS : respect of the French law (investigators meeting)

  Ø CNIL : for interventional trials (except routine care),

                 adherence to the methodology of reference MR001

  Ø Hospital agreements with CHUs and APHP (Guichet Unique)

    Services offered to conduct your studies in clinical research

  Ø Procedures in clinical research