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

s 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 '/>"/>

    SOURCE Reportlinker
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