Regulatory
Affairs

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.

Soporte ensayo clínico CRO Colombia

Review and concept to protocols

  • Review and concept to protocols
  • Protocol amendments
  • Review of new versions to consents / assents or additional to protocol
Desarrollo de protocolos ensayos clínicos CRO Colombia
  • Compliance with local regulation and GCP.
Desarrollo de protocolos ensayos clínicos CRO Colombia
  • Submissions to Ethics Committee and regulatory body.
  • Re-approval of the study