MOIRAX
EC, RA and CNOM submission
Contract negotiation
Feasibility and site selection
Site initiation visit including pharmacy and laboratory visits
Investigators training regarding GCP and SOP requirements, training site staff
Routine monitoring visits, Co-monitoring visits
Remote monitoring
Working with e-CRF (Rave Medidata®, Inform®, CTengine®)
Study drug accountability
Management of data queries
Coding
Reporting and follow up of SAEs
Collection and management of documents for the TMF
Study logistic and material
Site close out visits
Training of junior CRA
Therapeutic fields:
Oncology: solid tumor, chronic lymphocytic leukaemia , non small cells lung cancer, systemic anaplasic large cell-lymphoma, Hodgkin lymphoma (pediatric patients), prostate cancer
Cardiology: hypertension, hypercholesterolaemia
Rhumathology: arthrosis
Pneumology: asthma, COPD, allergy
Neurology: Alzheimer’s disease, multiple sclerosis, migraine
Endocrinology: somatotropic hormone, acromegaly, diabetes
Urology: prostatic hypertrophy
Haematology: anemia in oncology
Phlebology: oedema (medical device)
Periodontology: gingival inflammation
Dermatology: skin graft
