Our Geography
Clinical Trials in Russia, Ukraine and Byelorussia
Russia, Ukraine and Byelorussia offer excellent opportunities for sponsors to conduct clinical trial in compliance with GCP standards, international and local regulations, being attractive with fast subject recruitment for large-scale trials and trials in rare diseases, proved quality of the research data, and involvement of highly experienced and motivated investigators.
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Our Services
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Clinical Services
LEGE ARTIS privilege is our highly professional, experienced CRAs with excellent understanding of the drug development process and strong focus on achieving the project-based goals.
Medical Services
Being medical doctors (usually with a PhD degree in medicine) and specialists in different therapeutic areas, having many-years scientific research and/or university lecturer experience, and working at CROs for several years, LEGE ARTIS medical specialists bring clinical practice and research expertise together.
Regulatory Services
Well-qualified local partner with substantial expertise in local regulatory procedures could simplify the approval process of a clinical trial dramatically and reduce the timelines to the level comparable to the Western European standards.
Logistics
Clinical research practice in Eastern Europe, particularly in Russia proves that there are no minor or unimportant things in this business. Rapt attention to “routine details” is a factor of success in conducting clinical trials. LEGE ARTIS personnel have many-years experience in providing logistical support to clinical trials being conducted in Russia.
Quality Assurance
We strictly follow the high quality standards in all steps of our performance to ensure that the safety of human subjects is protected, subjects’ confidentiality is followed, the trial is performed and the data are generated, documented (recorded), and reported in timely manner and in compliance with Ethical principles, GCP guidelines, applicable regulatory requirements, and other essential documents.
Trainings
In order to ensure investigators’ proper qualification by education and training LEGE ARTIS provides high-quality, interactive, performance enhancing education and training to investigators and other site staff.
Supplemental Services
Attention to particulars is a key factor of the project success as a whole. Such particulars include, but not limited to, the activities, that LEGE ARTIS names “Supplemental Services”.
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18.02.2008
List of the clinical trials permitted for conducting in Russia during the fourth quarter 2007.
The list includes 174 clinical trials from phase I to phase IV, including multicenter international clinical research programs.
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04.02.2008
List of institutions authorized to perform pre-clinical trials (dated 24 January 2008)
On 30 January 2008 the Federal Service for Supervision in the Area of Health Care and Social Development published a list of the institutions authorized to perform pre-clinical trials in Russia.
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14.01.2008
List of the medical institutions that are accredited for conducting clinical trials in Russia (dated 09 January 2008)
List of the medical institutions that are accredited for conducting clinical trials in Russia - an update
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