Amber CRO

Amber CRO

Varkalu street 13A, Riga, LV-1067, Latvia

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+371 67896265

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About

AmberCRO is clinical research organization who conducts all clinical trials activities under GCP standards in Baltic States (Latvia, Lithuania and Estonia), Belarus, Russia, Ukraine and Georgia.

Mission 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.
Description

Amber CRO is a company established from the group of highly motivated and experienced professionals with several years of experience in Clinical Research field in Eastern Europe. Amber CRO is a reliable partner for pharmaceutical companies, CRO's and health care professionals. Amber CRO was founded in 2007 and since that has conducted many clinical trials in Baltic States (Latvia, Estonia and Lithuania), Belarus, Russia and Georgia. Within these years Amber CRO has received recognition by Latvian Minister of Economy, Investment and Development Agency in Latvia, Germany Federal Republic, European Business Awards, many pharmaceutical companies and CRO`s.

Awards AmberCRO has been awarded by the Latvian Governmental Institution (LIAA) during the competition organized by Latvian Minister of economy and LIAA (Investment and Development Agency in Latvia) on the 15th of December 2009 and on the 15th of December 2011.
AmberCRO has been selected as one of the National Finalists for European Business Awards 2012/2013 (country: Latvia).
AmberCRO has received appreciation for successful collaboration with the German companies on the 2010 and 2011.
Founded 5 April 2007
Products AmberCRO is performing Clinical trials Phase I-IV in Baltic States (Latvia, Lithuania and Estonia), Georgia, Belarus and Russia. The service range of AmberCRO consists of:
• Development of Study Design and Protocol, Case Report Form (EDC system) design and preparation;
• Site and Investigator selection (AmberCRO has its own data base with experienced sites and investigators (endocrinology, cardiology, inflammatory diseases, surgery, neurology, psychiatry, vascular surgery, gastroenterology, urology, oncology, dermatology, ophthalmology, rheumatology, family doctors, gynecology etc.).
• Feasibility processes, Site selection processes;
• Regulatory consultation. Preparation and submission of documents (clinical trial application/ Notification) to Regulatory Authority (-ies)/Ethics Committee;
• The performance of Qualification Visits;
• Independent Audit visits (for studies not managed by AmberCRO);
• Organization of Investigator meetings, training of Investigators;
• ICH/GCP training (for trial staff members and to CRA’s, SCRA’s, PM’s, CTC, CTA);
• Regulatory training (on regulatory requirements in regards to clinical trials of the particular country);
• Full Trial Site management and monitoring based on SOP's and study specific procedures:
Site Initiation
Monitoring visits
100% SDV
Adverse Event reporting
Site Close-out visits
Post-trial activities
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