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Reportlinker Adds Emerging Clinical Trial Locations - India: Market Dynamics and the Changing Healthcare and Regulatory Environment
Date:12/1/2009

kets. This report identifies market dynamics and key regulatory changes, and analyzes the implications and factors which need to be taken into consideration when conducting clinical trials in India.

Table of Contents

Emerging clinical trial locations - India

Executive summary 10

Introduction 10

Conducting clinical trials in emerging markets 11

India 12

Chapter 1 Introduction 14

Summary 14

Introduction 15

Generic competition 15

Intellectual property protection 15

Managing regulatory compliance 17

Cost containment and government funding restrictions 18

Obtaining and maintaining competitive advantage 18

Recruitment and retention of a skilled workforce 19

Improvement to R&D productivity 20

High risks and costs associated with drug development 20

Escalating costs of clinical trials 20

Global increase in the number of clinical trials conducted 23

Longer R&D timelines 24

Increased attrition rates during R&D 26

Clinical trial study design and planning 27

Clinical trial study design 27

Clinical trial study protocol 28

Clinical trial sponsors 28

Identifying and recruiting patients 28

Role of CROs 29

Information technology and new technology platforms 29

Drivers of development 30

Advantages associated with EDC 30

Advantages of electronic Clinical Trial Management Systems (CTMS) 30

Cost saving 31

Issues and challenges 31

Electronic records and signatures 31

Integration and linkage of electronic systems 32

Security and confidentiality of patient data 32

Chapter 2 Conducting clinical trials in emerging markets 36

Summary 36

Introduction 37<
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