Services

Regulatory Submissions for Clinical Trial Approval

 

CCDRD completely manages the regulatory submission process to receive clinical trial approvals in every region of operation. Appropriate SOP´s are in place for submission management of phase 1-4 trials.

Services offered:

  • Provision of required documents for submission at Ethics Committee(s) and Regulatory Authorities
  • Compilation of submission package for Ethics Committee(s) and Regulatory Authorities per country
  • Translations as required per country
  • Management and provision of subject insurance per country
  • Provision and management of contracts with sites and investigators as required per country
  • Interaction with Regulatory Authorities before, during and after the submission procedure