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