Clinical Trials in China
Universal Medica, March 2010, Pages: 175
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
ABSTRACT
INTRODUCTION
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
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