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Clinical Research Outsourcing and India


Description: Clinical research (CR) organization is one that manages a research or an investigation to assess and/or verify the clinical, pharmacological or other pharmacodynamic effects, safety and/or efficacy and adverse reactions of an investigational product. Clinical research (CR) organizations were primarily organized as outsourcing service companies that provided only clinical trial management. However, in recent times, most of them have expanded their scope of services to provide comprehensive management of complex drug trial processes for their client companies as well as to facilitate access to vast areas of expertise, which may not exist in the client's internal organization. Over the past few years, CR organizations have garnered bulk of the outsourced clinical research revenue share.

Till 1990, India was not the preferred destination for major global pharmaceutical companies, even though some of them were conducting clinical trials here. In the last 10 years however, there has been a steep rise in the global demand for world class clinical trial management capacity and productivity. With the average R&D expenditure growing at more than 15% per year, biopharmaceutical majors worldwide are realizing that the time-consuming and expensive affair of drug discovery and development can be done easier and better in India, given its rich technical resource pool, the relative ease & attractive economics of recruiting large number of patients and the sheer diversity inherent in the country’s genetic texture.

The international biopharmaceutical sector now finds India’s pool of highly skilled doctors, trained medical personnel, investigators, and the support research infrastructure to be highly attractive and as a result, large numbers of international companies are now viewing India as a potential center of knowledge, skills and resources, and are hoping to derive expertise-based synergies from Indian partners.

This report titled “Clinical Research Outsourcing and India” is based on extensive secondary research, well complemented by inputs from limited primary research, wherever found necessary. Apart from providing basic statistics on the domestic & global CRO market sizes, growth projections and market share details, this report provides ample qualitative coverage on the global clinical research industry, capturing all the recent key trends therein. The report outlines the top countries and companies that outsource and the selection criteria that are generally adopted by such global companies to evaluate Indian businesses before a decision is taken on outsourcing clinical research activities. The report explores emerging business models, growth drivers, and the scope for outsourced clinical research business in a country like India and, consequently, the strategies that have been adopted by the contract research organizations and their plans to grab their share of the global CRO pie.


Contents: Executive Summary
Introduction and Methodology
About the Report
Research Methodology
Overview of Clinical Research
Clinical Research:An Introduction
Clinical Research: Definition.
Types of Clinical Research and Major Sub-Segments
Key Constituents of a Clinical Research Team
The Global Scenario
Overview of the Global Scenario
Major Outsourcing Countries and Companies
The Indian Scenario
Clinical Research in India: Brief History
Extent of Clinical Research Outsourcing in India across Stages of Drug Development
India-Based Clinical Research Organizations
Major Companies: Strategies and Approaches
Clinical Research in India: Drivers and Hurdles
Hurdles to CROs
Key Growth Drivers
The Indian Advantage
Selection Process and Evaluation Methods by Global Outsourcing Companies
General Process Adopted by Global Companies
Evaluation Factors
How are Indian CROs Planning Ahead?
Expectations of Business Growth
Major Investments and New Capacities in India
Business Models and New Growth Avenues
Business Models
Growth Avenues
Indian Clinical Research: A SWOT Perspective
Outlook

Annexure
Annexure I – Clinical Research Protocols
Annexure II – Government Regulations Concerning Human Trials
Annexure III – Global CROs - Profiles
Annexure IV – Indian CROs – Profiles
Annexure V - Glossary of Clinical Research terms
Annexure VII – List of Exhibits


Methodology Our patented INTELLISEARCH methodology was used extensively to scour Web sources, and other paid databases and print publications were also consulted in addition, to prepare this report. The limited but comprehensive primary research study was carried out among select respondent categories including existing clinical research organizations and potential players, major drug producers, and technical experts.


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