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This service aims to provide management services for all or part of the clinical trial (Phases I to IV and related phases), from the protocol design to the integrated study report.
The mission is entrusted to experienced collaborators, accustomed to rigorous working practices, and who are capable of integrating quickly and effectively into the project team.
The use of new technologies and the setting up of an adequate organisation reaps significant benefits in terms of quality and timeliness.
- Elaboration of study documents
- Recruitment of Investigators
- Pre selection of Investigation Sites
- Investigator Meetings
- Set-up of Investigation Sites
- Investigation Site Audits
- Monitoring Visits
- Management of DCFs
- Management of SAEs
- Source data verification
- Management of therapeutic units
- Closure of Sites
- Blind-review, definition of analysis populations
- Monitoring Reports