PARIS
START-UP ACTIVITIES
Feasibility questionnaires (phone, email)
Pre-study visits as per study requirements (France, Denmark, Finland, Belgium)
Budgets/contracts negotiations with investigators as per trial team instructions (France,Switzerland)
TRAINING / MENTORING
Sites staff training on protocols and ICH/GCP
Mentoring/training of a junior local CRA
Training of new CRAs (including co-monitoring visits)
Development and translation of site specifics tools to help the staff on a day-to-day basis
REGULATORY
Ethics Committees submissions (initial and amendments) (France and Switzerland) with adaptation of PIS/ICF and protocol synopsis to both countries requirements
AFSSAPS (French HA) submissions (initial)
Swissmedic (Swiss HA): lending support to the regulatory department for submission
MONITORING
Initiation, monitoring and close-out visits (France & Switzerland)
PROJECT MANAGEMENT/ COORDINATION
Creation, implementation and handling of a payment process so as to perform monthly payment of 25 study staff according to the visits performed and monitored by the CRAs via a specific visit tracker
Tracking of 3 CRAs (in South Africa) activities for follow-up on study milestones progression
Leader and facilitator of internal and external conference calls
Coordination of project assistants in countries involved in a study to ensure trackers’ update nationally, and appropriate maintenance of country site files
THERAPEUTIC AREAS/ PHASES
Phase II in Endocrinology (Type 2 diabetes)
Phase II in Pulmonary (Idiopathic pulmonary Fibrosis)
Phase III in Pulmonary (Pulmonary arterial hypertension)
Phase IV in Oncology/Pain (Breakthrough pain)
Phase II in Rheumatology (Rheumatoid Arthritis): Phase II in Rheumatology (Systemic Lupus Erythematosus)
Phase III in CNS (Schizophrenia) Project management in Finance
