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Clinical Trials in China - Market Analysis Report

Market Analysis Report "Clinical Trials in China" Details

Universal Medica Services

Thanks to its strong expertise of the Chinese healthcare market since 2005, Universal Medica’s mission is to support your development in China, by avoiding costly mistakes and increasing your profit, productivity and savings.
Phase IV clinical studies have become a major issue in post marketing drug development.
By combining both medical and marketing expertises, Universal Medica has major assets compared to regular CROs and is thus able to provide you with optimal post marketing studies.
Universal Medica’s team has a solid medical and scientific background to ensure medical writing and translation quality, data management quality for biostatistics, as well as marketing expertise to provide optimal message delivery to your targets.
Relying on a large pool of physicians for your operations, we give you a fast patient recruitment and smooth data collection. We grant you unique insight on Chinese medical practices and market.

Table of contents

EXECUTIVE SUMMARY

 

Chapter 1: POPULATION, HEALTHCARE SYSTEM AND PHARMACEUTICAL MARKET
  • Demographic trends
  • Major diseases evolution
  • Pharmaceutical market
  • China: emerging destination for out sourcing clinical research
Chapter 2: REGULATION AND LEGISLATION ENVIRONMENT
  • 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
  • Set-up process
  • Quality Assurance
  • Administration of investigational product
  • Monitoring process
  • Data management and biostatistics analysis
  • Summary
Chapter 4: ACTORS
  • Ethic committees
  • Clinical Trials sponsors
  • Investigation centers
  • CROs
Chapter 5: MARKET DRIVERS
  • Patient pool
  • Diseases
  • Availability of patients
  • Clinical trials investigators
  • Doctor-patient relationship
  • Major cost saving
  • Data quality
  • Financial support and incentives from the Chinese government
Chapter 6: MARKET BARRIERS
  • Complicated management
  • Monitor compliance: FDA /ICH Good Clinical Practices
  • Slow regulatory process
  • Ethical challenges
  • Increasing transparency of clinical trials required
  • Demography and epidemiologic data
  • Import licenses
  • Cultural challenges
Chapter 8: CLINICAL TRIAL STRATEGIES
  • Regulatory strategy
  • Strategy to address culture, language and logistical issues
CONCLUSION