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