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;
  • In 2013 foreign branch – AmberCRO Georgia – was established in Tbilisi, Georgia;
  • Since June 2017, our headquarters’ office is located in privately owned office building in Tiraine (Marupe region), Latvia.
  • In February 2018 the legal entity – AmberCRO Armenia Ltd. – was established in Yerevan, Armenia

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 35 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; Hemophilia A and B (coagulation factor VIIa).
Paediatric trials: Asthma; Moderate persistent asthma (12-15Y); Persistent asthma (1-5Y); Catecholamine-Resistant Hypotension Associated with Distributive Shock (2-17Y).
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-squamous non-small cell lung cancer; Retinal vein occlusion; Severe community acquired pneumonia; Lennox – Gastaut Syndrome; Elevated intra-ocular pressure; Clostridium difficile infection; Moderate to severe active rheumatoid arthritis; Abdominal hysterectomy.
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; Lennox – Gastaut Syndrome.
PHASE IV Indication of conducted clinical trial
Adult trial: Parkinson’s disease; Fabry disease
Clinical trials with devices Indication of conducted clinical trial
Adult trial: Arterial hypertension; Venous leg ulcers; Knee osteoarthritis; Microinjector in suprachordial injection.

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

AmberCRO data protection policy

AmberCRO is committed to respect the rights of natural persons towards their personal information, which is in possession of AmberCRO, according to requirements of General Data Protection Regulation (EU 2016/679) of European Union (including “rights to be forgotten”, provision of possibility to individual to be informed about the data collected, correctness of the data collected by AmberCRO and right for rectification of incorrect data, right to data portability etc.).

We have developed our own Data protection policy. They key points are:

  1. Requirements of GDPR are implemented in integrated management system of AmberCRO with release of Data protection policy. As all AmberCRO offices/legal entities (headquarters office in Latvia, foreign branch office in Georgia (AmberCRO Georgia Ltd.) and legal entity in Armenia (AmberCRO Armenia Ltd.)) are operating under mutual integrated management system, requirements described in Data protection policy apply to all AmberCRO offices/legal entities and corresponding positions within them;
  2. The legal basis for personal data processing include:
    • conclusion and execution of agreements;
    • compliance with external regulatory/legislative requirements applicable to business activities of AmberCRO;
    • consent of individual (data subject) provided to AmberCRO;
    • legitimate interests of AmberCRO.
  3. The legitimate interests for personal data processing include:
    • performance of business activities;
    • provision of services in the field of clinical research;
    • verification of individual’s identity before entering into any kind of contractual relationships;
    • to ensure the execution of contractual obligations;
    • verification of trial site staff members’ competence and suitability for clinical trial conduct;
    • compliance with all regulatory/legislative requirements for business activity conduct (including regulatory aspects covering clinical research);
    • to ensure smooth performance of integrated management system processes;
    • to ensure and enhance the quality of services;
    • to administer payments performed/to be performed by AmberCRO;
    • performance of activities for Clients’ retention (including obtaining of feedback on AmberCRO performance);
    • prevention of fraud and any risks (e.g., financial, damage to reputation etc.) to AmberCRO business activities;
    • turning to public administration and operations’ offices, and courts to protect the legal interests of AmberCRO;
  4. Since the establishment of the company, we have developed confidentiality measures that must be followed by all employees for handling of different types of data;
  5. Data storage requirements are described in internal standard operating procedures of AmberCRO;
  6. Since 2015 AmberCRO holds certification to information security standard ISO 27001:2013. The aim of information security measures is to protect employees of AmberCRO, Clients and partners from illegal and harmful, direct or indirect, conscious or unconscious actions of persons while processing data and information, which is in possession of corresponding persons, and while using certain equipment (laptop, cell phone) for performance of work-related duties. All necessary and applicable measures to enhance the security of data/information that is in possession of AmberCRO are implemented throughout integrated management system of AmberCRO;
  7. To improve user’s experience with AmberCRO web-page, cookies may be used. Cookies policy is available at AmberCRO web-page;
  8. Every individual who is/was interacting with AmberCRO on different matters can contact AmberCRO on data protection aspects via email: dataprotection@amber-cro.com.

Full version of AmberCRO Data protection policy is available at AmberCRO upon execution of Mutual Non-disclosure and Confidentiality agreement.