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市場調査レポート

臨床開発の新興市場:中欧・東欧

Emerging Markets Clinical Development Series: Central and Eastern Europe

発行 Cutting Edge Information 商品コード 143472
出版日 ページ情報 英文 187 Pages
納期: 即日から翌営業日
価格
こちらの商品の販売は終了いたしました。
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臨床開発の新興市場:中欧・東欧 Emerging Markets Clinical Development Series: Central and Eastern Europe
出版日: 2010年11月30日 ページ情報: 英文 187 Pages

当商品の販売は、2016年07月01日を持ちまして終了しました。

概要

当レポートでは、中欧、東欧における臨床開発市場について分析し、ロシア、ポーランドを中心とした各国別の動向とプロファイル、ベストプラクティスをまとめ、概略下記の構成でお届けいたします。

中欧・東欧における臨床開発:新興市場における主な臨床業務

  • 中欧・東欧のスコアリング
  • 調査方法
  • プロファイルした企業
  • レポートレイアウト
  • プロファイルレイアウト
  • 中欧・東欧における治験実施:成功のための提言

ロシア

  • 臨床環境概要
  • 臨床開発戦略
  • ベストプラクティス
  • 臨床開発プロファイル

ポーランド

  • 臨床環境概要
  • 臨床開発戦略
  • 臨床開発プロファイル
  • その他の中欧・東欧諸国における動向

臨床開発プロファイル

目次
Product Code: PH145

Abstract

The countries in Central and Eastern Europe provide ample opportunity for life sciences companies, especially in terms of clinical development. The number of treatment-naive patients in the region makes it an ideal location to host clinical studies. In fact, the population of Central and Eastern European countries exceeds that of either the United States or the five largest Western European markets combined. Furthermore, there is a lower saturation of competing trials within the region compared to other, more developed markets. Besides a large patient population, Central and Eastern Europe offers the drug and device industries a convenient location - especially for European-based countries - to conduct clinical studies. The region has a long history of clinical development, making it easier to find and train skilled investigators. 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 challenges 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. Use these data and best practices to avoid common pitfalls and solidify your clinical strategy:

  • Patient access: Russia and Poland offer a distinct advantage as emerging markets: 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.
  • Intellectual property protection: 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.
  • Convenience: 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.

Table of Contents

  • 9 Clinical Development in CEE: Leading Clinical Operations in Emerging Markets
  • 11 Scoring Central/East Europe
  • 31 Study Methodology
  • 32 Profiled Companies
  • 33 Report Layout
  • 34 Profile Layout
  • 37 Running Trials in Central/East Europe: Key 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
  • 13 Figure E.2: Number of Studies Registered by Region
  • 13 Figure E.3: Number of Studies Registered in Select Central/East European Countries
  • 15 Figure E.4: Scoring Central/East Europe: Patient Access
  • 15 Figure E.5: Scoring Central/East Europe: Patient Retention
  • 17 Figure E.6: Scoring Central/East 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/East Europe: Communication/Language
  • 23 Figure E.10: Scoring Central/East Europe: Trial Technology Infrastructure
  • 23 Figure E.11: Scoring Central/East Europe: Supply Chain Management
  • 25 Figure E.12: Scoring Central/East Europe: Available Knowledge Base
  • 26 Figure E.13: Scoring Central/East Europe: Data Standards
  • 26 Figure E.14: Scoring Central/East Europe: Investigator Standards
  • 27 Figure E.15: Scoring Central/East Europe: Site Management Standards
  • 28 Figure E.16: Average Percentage of Budget Saved by Running a Site in Central/East Europe
  • 29 Figure E.17: Average Percentage of Time Saved by Running a Site in Central/East Europe
  • 30 Figure E.18: Scoring Central/East 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: Percent 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: Health Spending by Sector (2005)
  • 117 Figure 2.5: Poland' s Share of the European Pharmaceutical Market (2009)

Clinical Development Strategy

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

CHARTS AND GRAPHICS

  • 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
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