Who we are...

The aim of the company’s existence is to provide the maximum contribution to the evaluation of quality and efficacy of new pharmaceutical products, treatment methods or medical devices in their creation process.

By company’s flexibility, cost-effectiveness and proactivity AmberCRO strives to provide the high-quality services in the field of clinical research to meet all requirements and complete satisfaction of the Client, which would result in long-term business relationships. That is the reason why AmberCRO is committed to the continual improvement.

The vision of the company is to become the most reliable partner to pharmaceutical companies, CROs and health care professionals in Northern part of Europe (Baltic States), Belarus and in Caucasus region (Georgia, Armenia).

As for the company that provides services, employees are the most valuable asset. The awareness on company’s quality policy and requirements of Integrated Management System of AmberCRO employees is achieved by thought-out training programs, regular face-to-face meetings and emphasizing the importance to fully comply with requirements of ICH/GCP, local regulatory requirements and with requirements of Clients.

History

  • AmberCRO was established in April 2007 by group of professionals experienced in field of clinical research;
  • Since its establishment AmberCRO is a privately owned company;
  • Since June 2017, our headquarters’ office is located in privately owned office building in Tiraine (Marupe region), Latvia.
  • In 2013 foreign branch – AmberCRO Georgia – was established in Tbilisi, Georgia;

Facts about company

  • AmberCRO is a full-service contract research organization;
  • We are performing management and supervision of clinical trials -phase I-IV - and observational studies;
  • AmberCRO currently covers 6 operational countries – Latvia, Lithuania, Estonia, Georgia, Armenia and Belarus. In Russia – only monitoring activities are performed;
  • Potential operational country under exploration – Azerbaijan;
  • AmberCRO has collaboration partners (CROs) in Slovakia, Russia, Ukraine, Hungary and Czech Republic;
  • More than 30 employees are currently involved in business activities of the company;

Certifications

Integrated Management System of AmberCRO is ISO 9001:2015 (quality management) and ISO 27001:2013 (information security) certified.

AmberCRO | ISO 9001 - Quality Management
AmberCRO | ISO 27001 - Information Security

AmberCRO business activity is CrefoCert Gold certified (excellent solvency certification).

CrefoCert Gold Certified

Experience

Phase I Indications of conducted clinical trials
Adult trial: Antitrypsin deficiency; Rheumatoid arthritis.
Paediatric trial: Respiratory syncytial virus.
Phase II Indications of conducted clinical trials
Adult trials: Complicated intra-abdominal infections; Steroid naïve patients with persistent asthma; Active rheumatoid arthritis; Fibromyalgia; Moderately to severely active rheumatoid arthritis; Haemophilia (A or B); Diabetes Mellitus Type 2; Castration resistant prostate cancer; Active psoriatic arthritis; Resistant chronic phase chronic myeloid leukemia; Hemophilia A and B subjects with an inhibitor.
Paediatric trials: Asthma; Moderate persistent asthma (12-15Y); Persistent asthma (1-5Y).
Phase III Indications of conducted clinical trials
Adult trials: Untreated or relapsed /refractory chronic lymphocytic leukemia; Glioblastoma; Arterial hypertension; Relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma; Breast cancer (G-CSF); Asthma; Diabetes Mellitus Type 2; COPD; Overactive Bladder; Treatment of anemia in chronic kidney disease patients not on dialysis; HER2-Positive metastatic breast cancer; CABP; Severe plaque psoriasis; Severe hemophilia A; Maintenance treatment of anemia in end stage renal disease subjects on stable dialysis; Growth hormone deficiency; Neovascular age-related macular degeneration; Rheumatoid Arthritis; Indolent non-Hodgkin lymphoma; Onychomycosis; Nail psoriasis; Complex regional pain syndrome; Hospital-acquired bacterial pneumonia, Ventilator-associated bacterial pneumonia or Healthcare-associated bacterial pneumonia caused by Gram-negative pathogens; Hospital-acquired bacterial pneumonia and Ventilator-associated bacterial pneumonia; Schizophrenia; Staphylococcus aureus bacteremia including infective endocarditis; Non-small cell lung cancer; Retinal vein occlusion; Severe community acquired pneumonia.
Pediatric trials: Complicated intra-abdominal infections; Asthma (12-17Y); Asthma (6-12Y); Moderate persistent asthma (6-11Y); Severe persistent asthma (6-11Y); Severe haemophilia A; Neurogenic detrusor overactivity; Mild to moderate onychomycosis; Acute bacterial skin and skin structure infections.
PHASE IV Indication of conducted clinical trial
Adult trial: Parkinson’s disease
Clinical trials with devices Indication of conducted clinical trial
Adult trial: Arterial hypertension; Venous leg ulcers; Knee osteoarthritis.

AmberCRO coverage

Latvia:

  • Monitoring activities
  • Regulatory activities
  • Contract negotiation activities
  • Brokerage activities
  • Project management activities
  • IMP and other study supply import

Lithuania:

  • Monitoring activities
  • Regulatory activities
  • Contract negotiation activities
  • Brokerage activities
  • Project management activities
  • IMP and other study supply import

Estonia:

  • Monitoring activities
  • Regulatory activities
  • Contract negotiation activities
  • Brokerage activities
  • Project management activities
  • IMP and other study supply import

Georgia:

  • Monitoring activities
  • Regulatory activities
  • Contract negotiation activities
  • Brokerage activities
  • Project management activities
  • IMP and other study supply import

Armenia:

  • Monitoring activities
  • Regulatory activities
  • Contract negotiation activities
  • Brokerage activities
  • Project management activities
  • IMP and other study supply import

Belarus:

  • Monitoring activities
  • Regulatory activities
  • Contract negotiation activities
  • Brokerage activities - collaboration with qualified partner
  • Project management activities
  • IMP and other study supply import - collaboration with qualified partner
  • Biological sample export