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

By providing an efficient communication flow our clinical trial management experts’ will ensure that your projects will be implemented according to high quality standards, on time and on budget.

Due to comprehensive and complete database of healthcare professionals and medical centers, we provides site management services with a view to helping pharmaceutical companies find the right Investigator to ensure the rapid and accurate completion of their clinical trial.

Our site management services include, but not limited to:

• Setting up agreements
• Database review and identification of patients
• Pre-screening and screening activities
• CRF Completion and query management

Our safety management services include, but not limited to:

• Safety management planning
• Adverse event handling
• Development of clinical safety documents
• SAE reporting management
• Safety reporting to Regulatory Authorities of Republic of Armenia / Ethics Committee
• Local literature monitoring

Our medical writing services include, but not limited to:

• Case report forms (CRFs)
• Clinical study reports
• Investigator brochures (IBs)

We provide high quality, efficient and cost-effective assistance for interaction with Regulatory Authorities/Ethics committees, submission of documents, obtaining of regulatory approvals and not only.

Pre submission assessment and consulting

• Assessment of registration dossiers (Module 1, 2, 3, 4 and 5)
• Identification of the weak points
• Suggestion of appropriate solutions

As well as preparation of CTD format dossier:

• Administrative part (Module 1)
• Quality Overall Summary (QOS) (Module 2.3)
• Nonclinical Overview/summary (Module 2.4/2.6)
• Clinical Overview/summary (Module 2.5/2.7)
• Module 3 (on the basis of the documents provided by the manufacturer)
• Module 4 and Module 5.

Regulatory submissions
Preparation of documentation according to national requirements for:

• Registration of medicines
• Renewals
• Variations

Our logistics services include, but not limited to:

• Import
• Customs clearance and approvals
• Storage, inventory
• Distribution and tracking
• Returns and destruction management