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Clinical Trials Abroad – ‘Back in the USSR’
Figure 2: Number of International Clinical Trials Approved in Russia
250
200
150
100
50
0
1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
(Q1–3)
Source: www.regmed.ru
created comprehensive standard operating procedures (SOPs) and active work of software producers such as Oracle in the Russian market
invented effective project management technology. is of fundamental importance.
Russian CROs provide the full spectrum of services, including regulatory In summary, by outsourcing drug development activities to local Russian
submissions, medical monitoring, project management, handling clinical CROs, pharmaceutical, biotechnology and generic drug companies can
trial supplies, reporting, medical writing and so forth. However, only a reduce their fixed costs and investment in infrastructure and focus their
few of them can provide the data management and biostatistics services resources on sales and marketing, drug discovery and other areas in
in accordance with the highest international standards. Therefore, the which they can best differentiate themselves. ■
DATA MANAGEMENT IN PHARMACEUTICAL RESEARCH & DEVELOPMENT 23
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