Monitoring in
Clinical Research

&

Services in
Clinical
Monitoring and Submissions

Monitoring and coordination of clinical trials

• Global coordination of projects
• Budget management
• Coordination and follow up by the CRAs
• Preparation for audits
• Feasibility studies and selection of investigating sites
• Meetings between investigators and training on GCPs
• Implementation / monitoring and closure of clinical trials
• Control of the data collection on paper or eCRF (EDC capture)
• Negotiation of hospital contracts and additional costs / investigator contracts
  

Regulatory submissions of clinical trials

Regulatory submissions for research involving human beings (Jardé Act):

• Interventional clinical research involving human beings (RBM)
• Interventional clinical research which does not involve medicines and with only minimal risks and constraints (usual care)
• Non-interventional clinical research in which all acts are performed and products are used in the usual way without additional or unusual procedures or diagnosis, treatment or monitoring (observational studies)
  

Preparation of patient consents and review of the  files before regulatory submission according to EU directives

Preparation of agreements with hospitals and investigators

Monitoring and implementation of updates regarding "regulatory watch"

Preparation of regulatory submissions concerning clinical trial files for medicines and / or medical devices with the following regulatory agencies:

• Ethics Committee - CPP
• Competent Authority - ANSM
  
• National Council of the College of Physicians - CNOM
  
• Advisory Committee on the data processing in research in the field of health - CCTIRS
• The National Commission on Informatics and Liberties - CNIL