Nexus-Europe GmbH: Project Management, Exhibitions, Technology Transfer, Marketing, Statistical Analyses

Pharmaceutical Services

Russia today is very important to biotech and pharmaceutical companies around the world. Here is why: New drug products must be approved by a health authority before they can be sold in any country. Human clinical trials are required to seek this approval. High costs and patient recruitment restrictions make clinical trials in North America and Europe very difficult and extremely expensive. The creation of Good Statistics Practice (GSP) now means that there are alternatives to companies when fulfilling this expensive and difficult task.

GSP is a set of principles and procedures for the conduct, analysis and reporting of human clinical trials. GSP is noted in regulatory requirements, standards and guidelines set by most health authorities, such as the U.S. Food and Drug Administration (FDA) and the Committee for Proprietary Medicinal Products (CPMP) in the European Community. GSP provides accurate and reliable results, and ensures the validity of the studies.

Russia is the top clinical trial venue today because of its very large volunteer patient population and its significantly lower medical and compensation costs. We have the local and regulatory knowledge, recruiter relationships, expertise and experience to run a successful and very economical clinical trial. The results of these trials are officially verified and issued by the Russian health authority and, again, these results are GSP compliant meaning they meet the requirements for clinical trials in the USA, Canada, the EU, and most other countries worldwide.

Without GSP compliant clinical trials your pharmaceutical product, no matter how beneficial or life changing it is, will not be approved for sale or distribution. Let us help you save patients without sacrificing your budget in the process.

 

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