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Reportlinker Adds Clinical Trials in China
Date:9/9/2010

NEW YORK, Sept. 9 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Clinical trials in China

http://www.reportlinker.com/p0292332/Clinical-trials-in-China.html

This report focuses on clinical trials in China. It identifies market dynamics, key regulatory changes, and analyzes the implications and factors which need to be taken into consideration when conducting clinical trials in China. The market analysis report "Clinical trials in China" will maximize your savings and avoid costly mistakes.

This report provides: 1. A better comprehension of the Chinese clinical trial market:

  • A global economic & demographic Chinese market review
  • A draw up of an up-to-date regulatory and legislation situation including all the major reforms related to clinical trials
  • A comprehensive analysis of the market drivers and barriers
  • The main actors of the market
  • An exhaustive list and analysis of the main CROs including contact database
  • The clinical study design and planning in China
  • An overview of the trends, opportunities and challenges for the future
  • Strategic recommendations

  • 2. Answers to your business interrogations:

  • Why has China become a key destination for clinical trials?
  • What are the major drivers of this geographic clinical trials decentralization?
  • What are the remaining challenges for multinational clinical trials?
  • What is the process of clinical trials for imported drugs?
  • What are the major types of clinical trials conducted in China?
  • How does SFDA reform the healthcare environment in order to be in accordance with Western countries regulatory environment?

  • 3. An exhaustive synthesis of the main CROs located in China:

  • Get an identification sheet per CRO
  • Know about their major activities
  • Have an exhaustive list of Multinational & National CROs settled in China
  • Have an overview of their pharmaceutical customers

  • ABSTRACTINTRODUCTION

    Chapter 1: MARKET DYNAMICS

    Demographic trends

    Major diseases evolution

    Pharmaceutical market

    China: emerging destination for outsourcing clinical research

    Related events

    Chapter 2: REGULATION & LEGISLATION ENVIRONMENT: KEY REGULATORY CHANGES

    Healthcare institutions

    Healthcare reforms

    Chapter 3: CLINICAL STUDY DESIGN & PLANNING

    Overview of a Clinical Trial

    Preparations and prerequisites for conducting a clinical trial

    Administration Submission - Protocol for a clinical trial

    Control of samples

    Setting up process

    Quality Assurance

    Administration of investigational products

    Monitoring Process

    Data Management and Biostatistics Analyses

    Summary

    Chapter 4: KEY MARKET DRIVERS

    Patient pool

    Diseases

    Availability of patients

    Clinical trials investigators

    Strong Doctor-Patient Relationship

    Major Cost saving

    Increasing importance of the Pharmaceutical Market in China

    Quality data

    Financial support and incentives from the Chinese Government

    Creation of the Chinese Clinical Trial Register (CHICTR)

    Chapter 5: KEY MARKET BARRIERS

    Complicated Management

    Monitor compliance: FDA / ICH GCP

    Slow regulatory process

    Ethical challenges

    Increasing transparency of clinical trials required

    Demography and epidemiologic data

    Import licenses

    Cultural challenges

    Chapter 6: ACTORS

    Ethic committees

    Clinical trials sponsors

    Investigation centers

    CROs

    Chapter 7: CLINICAL TRIAL STRATEGIES FOR SMALL PHARMACEUTICAL COMPANIES

    Regulatory strategy

    Strategy to address culture, language and logistical issues

    CONCLUSION & RECOMMENDATION

    Pros and Cons of conducting Clinical Trials in China

    Trends for the future

    APPENDIX

    INDEX

    REFERENCES

    To order this report:Pharmaceutical Industry: Clinical trials in China

    Pharmaceutical Business News

    More  Market Research Report

    Check our  Company Profile, SWOT and Revenue Analysis!Nicolas BombourgReportlinkerEmail: nbo@reportlinker.com US: (805)652-2626Intl: +1 805-652-2626
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