1.3 Clinical trial management & monitoring

Clinical monitoring services include, but not limited to:

  • Site identification and assessment
  • Ethics committee and regulatory authority submissions
  • Translation of all clinical study documents (to/from Armenian, English and Russian) according to the current medical terminology, including quality checks
  • Assistance in obtaining local insurance
  • Training of investigators and their teams (e.g. GCP, safety reporting, IMP handling etc.)
  • Oversight of the clinical trial for compliance with the protocol and applicable regulatory requirements
  • File compilation, review and maintenance
  • Support for site audits and inspections


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