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Contract Research Organization

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
Project management

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.

Site management

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
Pharmacovigilance and Clinical Drug Safety 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
Medical writing

Our medical writing services include, but not limited to:

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

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
Logistics

Our logistics services include, but not limited to:

 

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

Partners

Founded in
2000 Yerevan
AM

International
Award 2010
"European Quality"

Official
Representative
2012 Georgia

Laboratory
Complex 2012
"FDA Lab"

Certification
Body 2014
Customs Union

International
Accreditation
2015 ANAB

St. G. Narekatsi
Healing Center
2016

Scope of
Activities
2016