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Clinical Research in Asia. Woodhead Publishing Series in Biomedicine

  • ID: 2719514
  • May 2012
  • Region: Asia
  • 412 Pages
  • Elsevier Science and Technology
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Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis).

- Analysis from a leading and highly respected professional in the sector
- An overview of country-specific regulatory environments
- Discussion of challenges and solutions for clinical research

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Dedication

List of figures and table

Acknowledgments

List of abbreviations

Preface

About the author

Chapter 1: Clinical research in Asia: a brief overview

Abstract:

1.1 Background

1.2 Global pharmaceutical market

1.3 Clinical research business
a global overview

1.4 CRO services mix

1.5 The clinical research boom in Asia

1.6 Asian country segmentation analysis

1.7 Clinical trials in Asia

1.8 Inspection and data quality

1.9 Clinical research in Asia
SWOT analysis

Chapter 2: Clinical research in Japan

Abstract:

2.1 Background and history

2.2 Clinical research industry in Japan

2.3 The regulatory environment in Japan

2.4 Evolution of Japanese good clinical practice

2.5 Global clinical trials in Japan

2.6 Emerging outsourcing models in Japan

2.7 Japan's international strategic outlook

2.8 Future outlook

Chapter 3: Clinical research in India

Abstract:

3.1 Pharmaceutical industry background

3.2 History of clinical research in India

3.3 Evolution of clinical research in India

3.4 Regulatory environment in India

3.5 Clinical trial approval

3.6 Difference between ICH-GCP and Indian GCP

3.7 Regulatory inspections in India

3.8 Clinical research in India: PESTLE analysis

3.9 Future outlook

Chapter 4: Clinical research in China

Abstract:

4.1 Pharmaceutical market

4.2 Pharmaceutical investments in China

4.3 China's healthcare system

4.4 Healthcare delivery system

4.5 The importance of traditional medicine in modern healthcare

4.6 China's CRO market

4.7 Clinical trials in China

4.8 Accreditation of clinical trial sites in China

4.9 Clinical research in China
environmental analysis

4.10 Future outlook

Chapter 5: Clinical research in South Korea

Abstract:

5.1 Pharmaceutical industry overview

5.2 CRO market in South Korea

5.3 Clinical trial environment

5.4 Evolution of GCP in South Korea

5.5 Clinical trials in South Korea

5.6 Accreditation of medical centres

5.7 Environmental analysis

5.8 Future outlook

Chapter 6: Clinical research in Taiwan

Abstract:

Chapter 7: Clinical research in Singapore

Abstract:

7.1 Overview of the pharmaceutical industry in Singapore

7.2 Pharmaceutical investments in Singapore

7.3 Governing authority and regulatory structure

7.4 Healthcare system in Singapore

7.5 Clinical research in Singapore

7.6 CRO market

7.7 Clinical trials in Singapore

7.8 Evolution of GCP in Singapore

7.9 Role of clinical trial resource centre

7.10 Environmental analysis

7.11 Clinical trial challenges

7.12 Future outlook

Chapter 8: Clinical research in Thailand

Abstract:

8.1 Pharmaceutical industry in Thailand

8.2 The pharmaceutical regulatory environment

8.3 Pharmaceutical market

8.4 Clinical research in Thailand

8.5 CRO market in Thailand

8.6 Hospital systems in Thailand

8.7 Conducting clinical trials in Thailand

8.8 Clinical trials in Thailand

8.9 Environmental analysis

8.10 Future outlook

Chapter 9: Clinical research in Malaysia

Abstract:

9.1 Pharmaceutical industry overview

9.2 Pharmaceutical market

9.3 Pharmaceutical regulation

9.4 Healthcare systems in Malaysia

9.5 Clinical trial environment

9.6 Regulatory environment in Malaysia

9.7 Evolution of Malaysian GCP

9.8 CRO market in Malaysia

9.9 Clinical trials in Malaysia

9.10 Registration of clinical trials

9.11 Challenges and future outlook

Chapter 10: Clinical research in Hong Kong

Abstract:

10.1 Background and history

10.2 Pharmaceutical industry in Hong Kong

10.3 Healthcare system in Hong Kong

10.4 Clinical trials in Hong Kong

10.5 The regulatory environment

10.6 Clinical trials in Hong Kong

10.7 Environmental analysis

10.8 Future outlook

Chapter 11: Clinical research in the Philippines, Indonesia Vietnam

Abstract:

11.1 Clinical research in the Philippines

11.2 Clinical research in Indonesia

11.3 Clinical research in Vietnam

Chapter 12: Conclusions

Abstract:

12.1 PESTLE analysis

12.2 Political environment

12.3 Economic environment

12.4 Socio-cultural forces

12.5 Technological factors

12.6 Legal environment

12.7 Other environmental factors

12.8 Strategic issues for the CRO industry

12.9 Future outlook

Bibliography

Index

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Sahoo, U
Dr Umakanta Sahoo is Executive Director for Asia Pacific and Managing Director for India at Chiltern, a Contract Research Organisation. He is a bioscience graduate with an MBA and PhD in Management, and has over 17 years of experience in the pharmaceutical industry and CRO sector.

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