12

Jul

Clinical Research in Eastern Europe Articles

Irina Petrova, Director of Clinical Operations for OCT Clinical Trials, explores why U.S. and other international companies are turning to Russia as a clinical research destination.

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05

Jun

Interim Analysis as a Key Decision-Making ToolArticles

Good Clinical Practice dictates stricter compliance with the fundamental concepts of conducting interim analysis by Russian pharmaсeutical companies, mainly because of the additional organizational resources it requires. On the other hand, the methodology and principles of deciding on the necessity of carrying out an interim analysis are not always properly reflected in a research protocol.

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29

Mar

Russia Opens the Door for Stem Cell Clinical TrialsArticles

While the US, Europe and some Asian countries have had a fully functional, comprehensive regulatory platform for BCP procedures for over two decades, Russia is relatively new to the area, only recently approving a regulatory framework.

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04

Oct

Patterns of collaboration between medical writers and biostatisticians Articles

The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely with biostatisticians within their organizations.

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13

Nov

Nonclinical studies in the Russian FederationArticles

Drug product developers and sponsors face a number of problems when organizing a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centers, complicating adaptation of the available experimental data to domestic legislation.

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