Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Emerging Market for Clinical Trials in Russia - Introduction
2.1 GBI Research Report Guidance
3 Emerging Market for Clinical Trials in Russia – Overview
3.1 The Clinical Research Process – Overview
3.1.1 Drug Discovery Phase
3.1.2 Pre-Clinical Phase
3.1.3 Phase I
3.1.4 Phase II
3.1.5 Phase III
3.1.6 Review and Approval from the Regulatory Agencies
3.1.7 Post-marketing Studies
3.2 Clinical Trials in Russia - Market Overview
3.2.1 Major Countries Sponsoring Clinical Trials in Russia, 2008-2010 (Jan-June)
3.2.2 Major Companies Sponsoring Clinical Trials in Russia, 2009
3.2.3 Clinical Trials Conducted in Russia by Indication, 2009
3.3 Clinical Trial Market Structure in Russia
3.3.1 Clinical Trials Conducted in Russia by Study Type
3.3.2 Foreign Sponsored Clinical Trials Conducted in Russia by Phase
3.3.3 International Multicenter Clinical Trials Conducted in Russia, 2004-2009
3.3.4 Local Clinical Trials Conducted by Local Sponsors in Russia, 2004-2009
3.3.5 Bioequivalence Studies Conducted by Local Sponsors in Russia, 2004-2009
3.3.6 Local Clinical Trials Conducted by Foreign Sponsors in Russia, 2004-2009
3.3.7 Approved Foreign Clinical Trials in Russia, 2004- 2010 (Jan - June)
3.4 The Need for Outsourcing Clinical Trials
3.4.1 High Risks and Costs Associated With Drug Development
3.4.2 Escalating Costs of Clinical Trials
3.4.3 Global Increase in the Number of Clinical Trials Conducted
3.4.4 Restructuring the R&D
3.4.5 Increased Screening Rates during R&D
3.4.6 Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs
4 Emerging Market for Clinical Trials – Russia - Clinical Trial Trends
4.1 Registration of Phase l Clinical Trials
4.2 Registration of Phase lI Clinical Trials
4.3 Registration of Phase lII Clinical Trials
4.4 Registration of Phase lV Clinical Trials
4.5 Clinical Trials Registered in 2010
5 Market Environment Characterization
5.1 CRO Market in Russia, Market Forecast up to 2017
5.2 Market Drivers
5.2.1 Low Cost of Conducting Clinical Trials
5.2.2 High Patient Recruitment Rate
5.2.3 High Incidence rate of few Diseases as compared to other Countries
5.2.4 Availability of Drug-Naïve Patients
5.2.5 High Patient Compliance
5.2.6 Good In and Out- Patient Facilities
5.2.7 Presence of Experienced Investigators for Clinical Trials
5.2.8 Good Quality of Clinical Trial Data because Local GCP is identical to ICH GCP
5.3 Market Restraints
5.3.1 Increase in the Cost of Experienced Study Staff
5.3.2 Limited Experience of Newly Qualified Sites
5.3.3 Declining Population of Russia
6 Emerging Market for Clinical Trials – Russia, Health Statistics
6.1 Key Parameters of Russian Population
6.2 Characteristics of Active Trials in Russia
6.3 Patient Availability for Major Diseases
6.3.1 HIV-AIDS
6.3.2 Cancer
6.3.3 Diabetes
6.4 Tuberculosis (TB)
6.5 Mortality by Major Diseases in Russia
6.6 Medical Infrastructure in Russia
7 Regulatory Landscape
7.1 Documents to be Submitted for Clinical Trial Approval
7.2 Recent Regulatory Changes in Russia
7.3 Timelines for Getting Approval for Conducting Clinical Trials in Russia
8 Emerging Market for Clinical Trials – Russia- CRO Landscape
8.1 Key CRO Companies- Profile
8.1.1 Synergy Research Group
8.1.2 Quintiles
8.1.3 PPD
8.1.4 ICON
8.1.5 PAREXEL
8.1.6 INC Research
8.1.7 Omnicare Clinical Research
8.1.8 Pharm-Olam
8.1.9 FOCUS Clinical Drug Development
8.1.10 Global Clinical Trials
8.1.11 PSI
9 Emerging Market for Clinical Trials – Russia - Appendix
9.1 Market Definitions
9.2 Abbreviations
9.3 Research Methodology
9.3.1 Coverage
9.3.2 Secondary Research
9.3.3 Primary Research
9.3.4 Expert Panel Validation
9.4 Contact Us
9.5 Disclaimer
9.6 Sources