Communication with Ethics Committees and Regulatory Agency can be performed by Coltrials regardless of the phase of the clinical research trial.
We are aware of and apply: Current Regulation and Good Clinical Practice (GCP) standards.
Review and concept to protocols
- Review and concept to protocols
- Protocol amendments
- Review of new versions to consents / assents or additional to protocol
- Compliance with local regulation and GCP.
- Submissions to Ethics Committee and regulatory body.
- Re-approval of the study