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Why Global CROs Outsource to Local CROs — and Why You Should, TooArticles
Sponsors often choose to work with global CROs when offshoring clinical trials, particularly for multinational studies.There are a few areas however where local CROs can have a significant positive impact on a trial’s conduct.
What should you know before filing regulatory submissions for clinical trials in Russia?Articles
Find out about key components to be aware of when submitting study approvals for running clinical trials in Russia.
Four Key Factors in Choosing a CROArticles
As the healthcare and life sciences industries have moved toward outsourcing models in clinical research, pharmaceutical and biotechnology companies face the challenge of finding the right Contract Research Organization (CRO) to assist in the clinical development of their treatments and medical devices. Although on the surface some services may seem similar, not all CROs are created equal.
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.
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.
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.
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.
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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