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.
- 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