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Regulatory Support

GAIC provides support to clinical studies submission to the CAML Ethics Committee  by: 

  • Managing documentation collection and revision required for EC submission (e.g. Study Authorization Letter, Investigator’s CV, EC questionnaire, etc.);
  • Reviewing and ensuring the follow-up of all the submission process until all required approvals are obtained;
  • Amendments and reporting management. 

Please check CNPD requirments.

Please contact us prior to Centre submission to obtain the updated checklist of documents and necessary templates.

 

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