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Clinical Trials


Clinical trials in Russia 2008

Russia compared to other countries

Publication Date   April 2008
Publisher   PMR Publications
Product Type   Report
Pages   66
ISBN Number   not applicable
Product Code   PMR011
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Price £1,205.00

approximately: $1,849 | €1,417

Summary


Based on a comprehensive survey carried out on the management staff from almost fifty companies, Clinical trials in Russia 2008 offers an extensive overview of Russia's clinical trials market in the context of other Central and Eastern European countries. Its exhaustive analysis of current and prospective market trends and a detailed discussion of the market's legal aspects, provide an all-embracing picture of the sector.

As a supplement, the report offers a directory of Contract Research Organisations and pharmaceutical companies active in clinical trials in Russia. In this directory of major players you will find an easy reference to such information as contact details (adress, telephone and fax number, e-mail address, website) as well as brief description of a company in case of CROs).

Key sections

  • Section one provides extensive information on the clinical trials market in Russia. It discusses its size and structure, as well as the number of trials and patients involved. It presents forecasts for 2008- 2012 and analyses current and anticipated market growth opportunities and obstacles. It also includes information on profiles and market situation of companies active on the market in 2006 and 2007.
  • Section two analyses the results of a survey carried out among such research companies. It evaluates the current market situation, and presents forecasts for the year 2008. Business development opportunities and obstacles are discussed, together with market development expectations of companies for 2008-2009. It also compares Russia's clinical research environment with that of other countries in Central and Eastern Europe.
  • Section three provides readers with essential and up-to-date information on the legal aspects of clinical research in Russia.
  • Section four examines basic attitudes to clinical trials in Russia.
  • Section five presents some basic facts on demography and healthcare in Russia, with special attention given to Russia's population, its density and the prevalence of illnesses in the country.

Report overview

Following a brief summary, background presentation and a description of the methodology employed in the report, Clinical trials in Russia 2008 provides an in-depth overview of the Russian clinical trials market with special emphasis on:

  • the market's size and structure
  • the number of trials and patients involved, followed by forecasts for 2008-2012
  • current and anticipated market growth opportunities and obstacles.

The report then presents characteristics of the main companies conducting clinical research in Russia in 2006 and 2007, with special focus on:

  • companies' origins and workforce
  • the number of patients participating in trials per company
  • companies' main areas of interest, according to therapeutic groups and study phases.

We then discuss a survey carried out on the management staff of companies active on the market.

The results include the following:

  • an evaluation of the current situation on the clinical research market and forecasts for 2008
  • opportunities for and obstacles to business development on the market
  • a market development forecast for 2008-2009
  • a comparative analysis of the clinical research environment in Russia and in other Central and Eastern European countries
  • the average registration time for clinical trials in Russia.

The report also provides a thorough examination of the legal aspects and conditions of clinical research, with special attention given to the following issues:

  • major legislation governing clinical research in Russia
  • principles and procedures in clinical trials
  • side effects and safety monitoring
  • insurance for clinical trials
  • taxes
  • contracts and fees in clinical trials.

Finally, the report outlines the prevailing attitudes to clinical trials in Russia and presents some basic facts on demography and healthcare in the country, with particular emphasis on:

  • Russia's population and its density
  • prevalence of illnesses in Russia.

This report is essential reading for:

  • the senior management of companies active on the clinical trials market
  • clinical Research Organisations and pharmaceutical companies interested in launching operations in Russia or cooperating with their Russian counterparts
  • companies interested in providing medical products and equipment for the clinical trials market in Russia
  • pharmaceutical companies and CROs keen to keep track of Russia's rapidly growing clinical trials market
  • decision makers who, for professional reasons, need to gain a thorough understanding of the key trends on the market.

Content


  • Report methodology
  • Executive summary
  • Background
  • Overview of the Russian clinical trials market
    • Size of the clinical trials market in Russia
    • in 1997-2007
    • Structure of the clinical trials market
    • Number of trials and patients participating in trials, with forecasts for 2008-2012
    • Patient recruitment
    • Infrastructure of clinical trials
    • Major events and trends on the clinical research market in Russia
      • Current events and trends
      • Anticipated trends
  • Largest companies conducting clinical research in Russia in 2006 and 2007
    • Largest international sponsors in Russia
    • Largest national sponsors in Russia
    • Workforce size and characteristics
    • Number of patients participating in trials
    • Main areas of interest of companies conducting
    • clinical trials in Russia
    • Phases of clinical trials conducted in 2007
    • Foreign operations of local firms
  • Results of survey among companies conducting clinical research in Russia
    • Introduction
    • Evaluation of situation in Russian clinical research market
    • Assessment of current market situation
    • Forecasts of market situation in 2008
    • Opportunities and barriers to business development in the clinical trials market in Russia
    • Key barriers to business development
    • Pros and cons of regionalisation of clinical trials in Moscow and other regions
    • Key factors conducive to development of operations
    • Market development expectations in the years 2008-2009
    • Time required to register clinical trials in Russia
    • Assessment of financial situation
    • Foreign operations
    • Comparative analysis of the clinical research environment in Russia and selected other countries
  • Legal aspects of clinical research
    • Most important institutions on clinical research market in Russia
    • Major legislation regulating clinical trials in Russia
    • Approval for conducting clinical trials in Russia
    • Principles of Good Clinical Practice
    • Procedures connected with the work of ethics committees
    • Occurrence of side effects and adverse events during clinical trials
    • Inspection of clinical trials
    • National inspections
    • FDA inspections
    • Imports of medicinal products for use in clinical trials
    • Insuring clinical trials
    • Tax on clinical trials
    • Contracts in clinical trials
    • Fees in clinical trials
    • Laboratory and diagnostic services
  • Attitudes to clinical trials in Russia
    • General attitudes towards clinical trials
    • Effectiveness of recruitment tools
    • Physicians' attitudes
    • Officials' attitudes
  • Basic demographic facts
    • Russia's population and its density
    • Prevalence of illnesses in Russia
  • About PMR
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