Abstract
What does a project manager mean by the term ‘quality clinical trial’? There is no universally acceptable definition, but to a project manager, a quality clinical trial means a well-designed trial that is performed in full compliance with GCP, study protocol and company procedures, within budget and on time. Obviously, the study has to be quality assured for the data to be reliable. Conducting a quality study in Russia is as challenging as it is anywhere else. A lot has been published to date on how to achieve quality in drug development regardless of the country where the research is conducted. Since necessary practical skills tend to differ more or less from country to country, the purpose of this paper is to present a close-up view of certain practical issues associated with carrying out clinical trials to international standards in Russia. © 1997 John Wiley & Sons, Ltd.
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