Emerging Markets Clinical Trials: Eastern Europe

$995.00

Use this study as a resource to design and prepare your company’s clinical trials in Central and Eastern Europe. The report addresses, in detail, the cultural
challenges in clinical trials and clinical development opportunities that these emerging markets provide. It provides detailed benchmark metrics for Russia, Poland, the Balkans, Bulgaria, Romania, Turkey and Ukraine, all in one place. Learn the advantages and challenges that each of these countries present.

Download a benchmarking report summarySpeak to a pharmaceutical benchmarking expert

Report Details

Publication Date: November 2010
Pages: 187
Chapters: 3
Metrics: 400+
Charts/Graphics: 127
Profiles: 18

Top Reasons to Buy this Emerging Markets Clinical Trials Eastern Europe Report

Improve Patient Access:  Russia and Poland offer a distinct advantage as emerging markets clinical trials eastern europe: access to treatment-naive patients. Recruitment and retention are strong in these countries as well. This report will guide your decision-making process as you determine how to run a trial in a Central or Eastern European nation.

Protect Intellectual Property:  IP issues can be daunting when working in an emerging market. This study shows you how to work with local partners to navigate culture and regulations, avoid the threat of corruption and protect your intellectual property.

Tap Geographic and Cultural Proximity:  Russia, Poland and the other countries profiled in this report offer the advantage of being neighbors to Western Europe. This means that the local investigator knowledge base is similar to that of Western European countries, and EU-EC guidelines for GCP are becoming more commonplace. Learn about the other advantages that the central and eastern European countries offer to clinical development teams.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource as well as our individual clinical development research reports.

Excerpt from Emerging Markets Clinical Development Series Central and Eastern Europe

The emerging markets offer hope to an industry struggling with patent cliffs, price cuts and an uncertain economy. Countries such as Brazil, Russia, India and China (BRIC) often highlight the emerging markets discussion, though regions worldwide can benefit pharmaceutical and device companies. For many companies looking to expand their marketing operations into emerging markets, the first step is often clinical development. It allows a company to begin networking with regulatory officials and key opinion leaders and introduces the company to distinct cultural differences associated with these new markets.

Running trials in emerging markets — from the often-discussed BRIC countries down to countries with less than 10 million inhabitants — is not always easy, and few companies would claim to have conquered all challenges. Questions of quality, regulations, culture and cost plague clinical development teams. Attempting to differentiate scores of possible clinical trial locations produces reams of data and leaves these teams unsure of the best strategic locations for their trials.

Table of Contents

9              Executive Summary

11           Scoring Central/East Europe

31           Study Methodology

33           Report Layout

34           Profile Layout

37           Running Trials in Central/East Europe: Recommendations for Success

45           Russia

47           Clinical Environment Overview

60           Clinical Development Strategy

76           Best Practices

80           Clinical Development Profiles

105         Poland

106         Clinical Environment Overview

118         Clinical Development Strategy

134         Clinical Development Profiles

159         Working in Other Emerging Central and Eastern European Countries

164         Clinical Development Profiles

Charts and Graphics

Executive Summary

Scoring Central/East Europe

12           Figure E.1: Central/East European Population Compared to US and 5 EU Countries

13           Figure E.2: Number of Studies Registered by Region

13           Figure E.3: Number of Studies Registered in Select Central/Eastern European Countries

15           Figure E.4: Scoring Central/Eastern Europe: Patient Access

15           Figure E.5: Scoring Central/Eastern Europe: Patient Retention

17           Figure E.6: Scoring Central/Eastern Europe: Regulatory Environment

18           Figure E.7: Scoring Central/East Europe: Intellectual Property Laws/Practice

19           Figure E.8: Scoring Central/East Europe: Cultural Concerns

21           Figure E.9: Scoring Central/Eastern Europe: Communication/Language

23           Figure E.10: Scoring Central/Eastern Europe: Trial Technology Infrastructure

23           Figure E.11: Scoring Central/Eastern Europe: Supply Chain Management

25           Figure E.12: Scoring Central/East Europe: Available Knowledge Base

26           Figure E.13: Scoring Central/Eastern Europe: Data Standards

26           Figure E.14: Scoring Central/Eastern Europe: Investigator Standards

27           Figure E.15: Scoring Central/Eastern Europe: Site Management Standards

28           Figure E.16: Average Percentage of Budget Saved by Running a Site in Central/Eastern Europe

29           Figure E.17: Average Percentage of Time Saved by Running a Site in Central/East Europe

30           Figure E.18: Scoring Central/Eastern Europe: Anticipated Cost

Russia

Clinical Environment Overview

47           Table 1.1: Key Demographic Figures for Russia (2010)

48           Figure 1.1: Change in Life Expectancy: Russia (1960-2050)

49           Table 1.2: Top 10 Causes of Death in Russia (2002)

50           Figure 1.2: Ethnicities in Russia (2002 Census)

53           Table 1.3: Key Economic Figures (2009)

55           Table 1.4: Key Healthcare System Figures (2005–2009)

56           Figure 1.3: Russia’s Healthcare Spending as a Percentage of GDP (2006)

57           Figure 1.4: Russia’s Health Spending by Sector (2005)

Clinical Development Strategy

61           Figure 1.5: Percentage of Total Trial Patients Enrolled in Russia

62           Figure 1.6: Percentage of Budget Saved by Running Trial in Russia

63           Figure 1.7: Percentage of Time Saved by Running Trial in Russia

65           Figure 1.8: Assigning Clinical Development Responsibilities for Russia

67           Figure 1.9: Importance of Factors that Impact Clinical Trial Environment for Companies Operating in Russia

68           Figure 1.10: Scoring Russia: Clinical Environment Scores

72           Figure 1.11: Importance of Factors that Impact Trial Operations for Companies Operating in Russia

73           Figure 1.12: Scoring Russia: Trial Operations Scores

Clinical Development Profiles

80           Figure 1.13: Profile 1: Company Background

81           Figure 1.14: Profile 1: Experience in Central and Eastern Europe

82           Figure 1.15: Profile 1: Clinical Strategy in Russia

83           Figure 1.16: Profile 1: Scorecard for Russia

84           Figure 1.17: Profile 2: Company Background

85           Figure 1.18: Profile 2: Experience in Central and Eastern Europe

86           Figure 1.19: Profile 2: Clinical Strategy in Russia

87           Figure 1.20: Profile 2: Scorecard for Russia

88           Figure 1.21: Profile 3: Company Background

89           Figure 1.22: Profile 3: Experience in Central and Eastern Europe

90           Figure 1.23: Profile 3: Clinical Strategy in Russia

91           Figure 1.24: Profile 3: Scorecard for Russia

92           Figure 1.25: Profile 4: Company Background

93           Figure 1.26: Profile 4: Experience in Central and Eastern Europe

94           Figure 1.27: Profile 4: Clinical Strategy in Russia

95           Figure 1.28: Profile 4: Scorecard for Russia

96           Figure 1.29: Profile 5: Company Background

97           Figure 1.30: Profile 5: Experience in Central and Eastern Europe

98           Figure 1.31: Profile 5: Clinical Strategy in Russia

99           Figure 1.32: Profile 5: Scorecard for Russia

100         Figure 1.33: Profile 6: Company Background

101         Figure 1.34: Profile 6: Experience in Central and Eastern Europe

102        Figure 1.35: Profile 6: Clinical Strategy in Russia

103         Figure 1.36: Profile 6: Scorecard for Russia

Poland

Clinical Environment Overview

106         Table 2.1: Key Demographic Figures for Poland (2010)

107         Figure 2.1: Change in Life Expectancy (1960–2050)

108         Table 2.2: Top 10 Causes of Death in Poland (2002)

109         Figure 2.2: Ethnicities in Poland (2002 Census)

112         Table 2.3: Key Economic Figures (2009)

113         Table 2.4: Key Healthcare System Figures (2005–2009)

114         Figure 2.3: Poland’s Healthcare Spending as a Percentage of GDP (2005)

115         Figure 2.4: Poland’s Health Spending by Sector (2005)

117         Figure 2.5: Poland’s Share of the European Pharmaceutical Market (2009)

118         Figure 2.6: Percentage of Total Trial Patients Enrolled in Poland

Clinical Development Strategy

119         Figure 2.7: Percentage of Budget Saved by Running a Trial in Poland

120         Figure 2.8: Percentage of Time Saved by Running a Trial in Poland

121         Figure 2.9: Assigning Clinical Development Responsibilities for Poland

125         Figure 2.10: Importance of Factors that Impact Clinical Trial Environment for Companies Operating in Poland

126         Figure 2.11: Scoring Poland: Clinical Environment Scores

130         Figure 2.12: Importance of Factors that Impact Trial Operations for Companies Operating in Poland

131         Figure 2.13: Scoring Poland: Trial Operations Scores

Clinical Development Profiles

134         Figure 2.14: Profile 7: Company Background

135         Figure 2.15: Profile 7: Experience in Central and Eastern Europe

136         Figure 2.16: Profile 7: Clinical Strategy in Poland

137         Figure 2.17: Profile 7: Scorecard for Poland

138         Figure 2.18: Profile 8: Company Background

139         Figure 2.19: Profile 8: Experience in Central and Eastern Europe

140         Figure 2.20: Profile 8: Clinical Strategy in Poland

141         Figure 2.21: Profile 8: Scorecard for Poland

142         Figure 2.22: Profile 9: Company Background

143         Figure 2.23: Profile 9: Experience in Central and Eastern Europe

144         Figure 2.24: Profile 9: Clinical Strategy in Poland

145         Figure 2.25: Profile 9: Scorecard for Poland

146         Figure 2.26: Profile 10: Company Background

147         Figure 2.27: Profile 10: Experience in Central and Eastern Europe

148         Figure 2.28: Profile 10: Clinical Strategy in Poland

149         Figure 2.29: Profile 10: Scorecard for Poland

150         Figure 2.30: Profile 11: Company Background

151         Figure 2.31: Profile 11: Experience in Central and Eastern Europe

152         Figure 2.32: Profile 11: Clinical Strategy in Poland

153         Figure 2.33: Profile 11: Scorecard for Poland

154         Figure 2.34: Profile 12: Company Background

155         Figure 2.35: Profile 12: Experience in Central and Eastern Europe

156         Figure 2.36: Profile 12: Clinical Strategy in Poland

157         Figure 2.37: Profile 12: Scorecard for Poland

Working in Other Emerging Central and Eastern European Countries

Clinical Development Profiles

164         Figure 3.1: Profile 13: Company Background

165         Figure 3.2: Profile 13: Experience in Central and Eastern Europe

166         Figure 3.3: Profile 13: Clinical Strategy in the Balkans

167         Figure 3.4: Profile 13: Scorecard for the Balkans

168         Figure 3.5: Profile 14: Company Background

169         Figure 3.6: Profile 14: Experience in Central and Eastern Europe

170         Figure 3.7: Profile 14: Clinical Strategy in Bulgaria

171         Figure 3.8: Profile 14: Scorecard for Bulgaria

172         Figure 3.9: Profile 15: Company Background

173         Figure 3.10: Profile 15: Experience in Central and Eastern Europe

174         Figure 3.11: Profile 15: Clinical Strategy in Romania

175         Figure 3.12: Profile 15: Scorecard for Romania

176         Figure 3.13: Profile 16: Company Background

177         Figure 3.14: Profile 16: Experience in Central and Eastern Europe

178         Figure 3.15: Profile 16: Clinical Strategy in Romania

179         Figure 3.16: Profile 16: Scorecard for Romania

180         Figure 3.17: Profile 17: Company Background

181         Figure 3.18: Profile 17: Experience in Central and Eastern Europe

182         Figure 3.19: Profile 17: Clinical Strategy in Turkey

183         Figure 3.20: Profile 17: Scorecard for Turkey

184         Figure 3.21: Profile 18: Company Background

185         Figure 3.22: Profile 18: Experience in Central and Eastern Europe

186         Figure 3.23: Profile 18: Clinical Strategy in Ukraine

187         Figure 3.24: Profile 18: Scorecard for Ukraine