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Russia: Clinical Development Country Profile

  • October 2013
  • -
  • Industry Standard Research
  • -
  • 89 pages

ISR provides insight into the clinical development environment, sponsor and service provider activities, and population “health status” for Russia. With this report, sponsors and service providers can make informed strategic development decisions by understanding the benefits and drawbacks to conducting trials in Russia.

What you will learn in this report:
- On-the-ground insights from several industry KOLs from top pharma companies and country heads from multinational CROs
- How its economy and national policies make Russia an attractive country for clinical trial activity, and why regulatory uncertainty and process challenges remain
- Health statistics for Russia, including life expectancy, cancer and AIDS incidence rates, alcohol and tobacco consumption, and more (see table of contents)
- Capabilities of domestic service providers and contact details for domestic pharmaceutical companies
- Regulatory environment/ considerations and how they compare to EU standards

How you can use this report:
- Understand how sponsors and CROs view Russia as a site for clinical trials and where the country fits within their clinical development strategy
- Uncover logistical details for conducting Russian trials
- Illustrate the benefits and drawbacks of conducting trials in Russia
- Target specific indications by learning how Russia compares to other countries on a variety health statistics
- Set realistic expectations for trial operations and timing by reviewing historic, country specific trial metrics

Table Of Contents

Russia: Clinical Development Country Profile
Table of Contents

Copyright and Usage Guidelines 5
Methodology and Sources 6
Introduction .7
Industry Interviews 10
Sponsor Interview 10
CRO Interviews ..12
PPD ..12
Premier Research .17
Russia Health Statistics 23
Health status summary .24
Life expectancy .25
Cancer incidence rate 26
Female breast cancer incidence ..27
Male prostate cancer incidence 28
AIDS incidence ..29
HIV prevalence ..30
Tobacco consumption 31
Alcohol consumption .32
Prevalence of dementia 33
Total health expenditure as a share of GDP ..34
Clinical Trial Overview ..35
Protocol approval timelines 37
Regulatory Considerations ..38
Overview of Legal Obligations ..38
Comparison of Russian Clinical Trial Laws to EU Laws ..41
Medical Specimen Regulations .44
Clinical Trial Activity 46
Number of Clinical Trials ..47
Clinical trials, by phase ..47
Study type distribution (e.g. interventional) ..47
Interventional trials, by phase ..48
Observational trials, by phase 48
Industry-funded study type distribution ..49
Industry-funded interventional trials, by phase ..49
Industry-funded observational trials, by phase 50
Average Length of Clinical Trials ..51
Average trial length, by phase ..51
Average interventional trial length, by phase ..52
Average observational trial length, by phase 52
Average industry-sponsored interventional trial length, by phase 53
Average industry-sponsored observational trial length, by phase .53
Projected vs. actual ongoing trial length, by phase 54
Projected vs. actual ongoing interventional trial length, by phase .54
Projected vs. actual ongoing observational trial length, by phase .55
Projected vs. actual ongoing industry-sponsored interventional trial length, by phase .55
Projected vs. actual ongoing industry-sponsored observational trial length, by phase ..56
Average Clinical Trial Enrollment .57
Average enrollment by phase 57
Interventional enrollment, by phase .57
Observational enrollment, by phase ..58
Industry-sponsored, interventional trial enrollment, by phase 58
Industry-sponsored, observational trial enrollment, by phase .59
Selected Sponsor Distribution of Clinical Trials 60
Total sponsor distribution of clinical trials ..60
Funding Source Distribution of Trials .61
Total funding source distribution of trials ..61
Funding source distribution of phase I trials ..61
Funding source distribution of phase II trials .62
Funding source distribution of phase III trials 62
Funding source distribution of phase IV trials 63
Funding source distribution of no phase trials ..63
Clinical Service Provider Capabilities 64
Domestic Clinical Service Providers 68
ACCELL Clinical ..68
Accovion 69
Almedis .71
Congenix ..72
Cromos Pharma 74
Eastern Clinical Trials .78
Global Clinical Trials 79
MatrixPharm ..80
Outsourcing Clinical Trials 81
Synergy Research Group ..82
Domestic Service Provider Contact List 85
Domestic Pharma/CRO Association Members .86
Domestic Pharma Company List ..87
International Pharma Company List ..88
About Industry Standard Research 89

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