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Clinical Data Management in India


Description: The report on clinical data management provides an in-depth perspective of the sector from a number of important aspects. The report starts with the global electronic data capture market ,which offers the benefits of faster and more accurate data capture at lower cost. The report covers the CDM value chain, markets, major players, regulations, growth drivers, issues and challenges, critical success factors and merger trends. The report also analyses the performance of the industry keeping in view the critical success factors. Finally it highlights the certain issues and challenges faced by the industry. The report also profiles the major players in the industry.

Countries Covered: India


Contents: CONTENTS

1.Executive Summary

2.Highlights

3. Introduction

4. Scope and Business need
4.1 Business Need
4.2 Products
4.3 Services
4.4 EDC (electronic data capture)
4.4.1Market
4.4.2 Global scenario
4.4.3 EDC prospects
4.4.4 Indian scenario

5. Business Models.
5.1 Project-Level Contract model or preferred full service provider
5.2 Retained Full Time Equivalent (FTE) model
5.3 Functional Service Provider (FSP) model

6. CDM Value Chain

7. Tools and techniques for biological data Management

8. Critical success factors

9. IT Infrastructure
9.1. Data Management software systems
9.2 Clintrial
9.3 Data Coding
9.4 EDC (electronic data capture) form

10. Issues and challenges
10.1 Data Accuracy & Timelines
10.2 Skilled manpower availability
10.3 Patient Privacy & data confidentiality
10.4 Data Exclusivity
10.5 Regulatory Compliance

11. Market size
11.1 List of companies in India involved in CDM activity

12. Potential Customers for CDM Outsourcing

13. Major players
13.1 Major Companies

14. Regulatory Issues

15. Recent Merger & Acquisition
15.1 TCS in multi-million dollar deal with Swiss firm

16. Future outlook

Annexure I – Bibliography
Annexure II – Abbreviations

LIST OF FIGURES
Figure 4.1: Clinical Database
Figure 4.2: EDC Market size
Figure 7.1: Process of converting data to information
Figure 8.1: Cost structure of CDM companies
Figure 9.1: Mechanism of Clintrial

LIST OF TABLES
Table 4.1: Major Global EDC vendors
Table 10.1: Work force of some of the major companies in India into CDM
Table 11.1: Clinical Research Companies


Companies Mentioned Satyam Computers TCS-ATC Wipro Cadila Pharmaceuticals Limited SIRO Clinpharm Pvt. Ltd MANIPAL ACUNOVA LTD Asian Clinical Trials (ACT)


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