Local ethics committee

CRO

A Local Ethics Committee has been established at Convex Clinical Research Center. Its members helps facilitate a rapid study start-up. The committee operates in accordance with Standard Operating Procedures approved by the regulatory authorities in Bulgaria. The Ehics Committee aims at preserving the rights of patients and volunteers, as well as at ensuring their health and well-being during and after the completion of a clinical trial. Therefore, the Committee members review all available documentation regarding a clinical trial prior to its start. They also monitor the ongoing clinical trial in details and ensure the subjects’ physical and mental integrity. The Committee holds its meetings twice a month and consit of the following members:

  • Medical doctor – cardiologist
  • Medical doctor – pulmonologist
  • Medical doctor – pharmacologist
  • Medical doctor – internist
  • Accountant
  • Lawyer
  • Psychologist