Clinical Trial Authorization

/Clinical Trial Authorization
Clinical Trial Authorization Emmanuel Sanchez 2018-04-11T14:15:41+00:00

CLINICAL TRIAL AUTHORIZATION

Regulatory activities are managed by the Project Manager who works closely with the local team for French-speaking and English-speaking countries.

Compliance with local regulations is one of our commitments and is made possible by our regulatory surveillance, added by a documented monthly impact analysis and an adequate internal training.

 Preparation of the Clinical Trial Authorization Dossier :

  • Competent Authorities
  • Ethics Committee
    • Systematic validation of documents constituting the file
    • Collection and preparation of required documents
    • Adaptation and translation required
    • Preparation of the cover letter
    • Submission of the file
    • Follow up of any questions
  • Substantial and non-substantial changes management

Communication with Authorities during the study