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Clinical Data Management in India
Cygnus Research, November 2007, Pages: 66
Clinical Data Management (CDM) industry is the fastest growing and possibly the most profitable segment in Bio Services industry. During 2006-07 it grew to USD40 million, a growth of 53% over the previous year. There are over 70 companies in India offering services in this niche area. Most of them find it a logical extension of their other Bio services business. They include Contract Research Organisations , Clinical Trial Organisations, IT services companies and hospitals. Out sourced Clinical trails to India is a prime growth driver for this market, though they are a few large dedicated CDM companies as well. Indian clinical trials market in 2006 was USD140m and has been growing at a CAGR of 40% for the last 3 years and is likely to scale up to USD600 million by 2010. Correspondingly, CDM market is expected to ramp up to USD150 million by the same time.
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.
The report will be useful for all those that are interested in CDM industry like pharmaceutical companies, hospitals, CRO’s, IT companies , Investment Banks, Mutual Funds, Hedge Funds, Private Equity players, business analysts, consultants, investors and students.
Countries Covered: India
4. Scope and Business need
4.1 Business Need
4.4 EDC (electronic data capture)
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
9.3 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
The Clinical data management (CDM) involves the collection, data entry, validation, clinical coding and transfer of clinical trial data. The data is captured in a paper or EDC (electronic data capture) form, the system of data capture is slowly moving away from the traditional paper form to EDC form as 50% of the data capture is now done in electronic form and CDM companies are fast adopting this with products like Inform in good business. The type of companies involved in CDM activities are contract research organizations (CRO), Pharma companies and IT companies.
The service offerings in CDM are CRF (Case Report Form) development, logging, tracking and review; development of data entry, creation, validation, coding, security, archiving and double data entry; query management; statistical analysis; clinical study report; quality data audits and electronic data processing. The major products in CDM are SAS PheedIT, Oracle Clinical and Medidata Rave. The other products include clin-e2e, Clinic form, Clintrial, WINonline, NuGenesis, Seibel eClinical etc.
The popular business models in CDM are project level contract model or preferred full service provider - popularly used for individual or standalone service, retained full time equivalent (FTE) model - used when the service requirement is large and functional service provider (FSP) model – for multiple and large studies.
Electronic data capture can provide better data and a more efficient clinical trial process, including improvements in data quality, a streamlined review process and ultimately faster time to market. By reducing the length of the drug development process, sponsors can increase the return on their investment and better distribute their resources.
The CDM value chain consists of Standard Operating Procedures (SOP) which include generation of random codes, maintenance of blindness in a blind clinical investigation, database development and validation, label of investigational drug for clinical studies, review of protocol and CRF development, flow and tracking of CRF, data entry and correction, clinical database audit, programming development and statistical analysis, laboratory normal range processing, dictionary coding, randomization table generation, data security and warehousing.
Standard regulatory practices like US FDA (21CFR11) and ICH-GCP guidelines ensures that there is uniformity in data management practices globally including India. European Agency for the Evaluation of Medicinal Products (EMEA) and Ministry of Health, Labour and Welfare (MHLW) are region specific standards. The critical success factors for CDM in India are cost competitiveness, preferred clinical trials destination, large & long-term contracts, alliances & collaborations, regulatory compliance, modern infrastructure facilities, competency in CDM software, awards & accreditations / certifications, quality processes, knowledge workforce, funding, technology breakthroughs, dedicated marketing, easy accessibility and expertise in pharma value chain.
The IT infrastructure consists of data management software and systems, centralized database servers, web based data collection, EDC form, eDiaries / ePRO, imaging system, direct access solutions, ETL (Extraction, Transformation and Loading), clinical trial portals and data warehousing. The CDMS platform allows for configuration of the system for the specific project is only the starting point for handling the flood of clinical data for the drug development pipeline. The major issues and challenges in CDM are data accuracy & timelines, skilled manpower, patient privacy & data confidentiality, data exclusivity and regulatory compliance.
The totals spend in India on clinical trial research and management informatics, of which CDM forms a part, is around USD400-500 million. It accounts for 4-5% of the total global spending. The total CDM market in India is estimated to be USD30 million, the CDM forms a very small part of the portfolio of the giant outsourcing companies, for example - Satyam estimates that CDM contributes only around 1-2% of the annual revenues of the life sciences vertical.
Some of the major companies operating in CDM in India are Accenture, TCS (has a separate setup for CDM), Wipro (has a product), SIRO Clinpharm (managed more than 200 projects in CDM), Manipal Acunova (first university CRO in India and ISO 9001:2000 certification) etc.
Indian industry, which previously was relied on its cost effectiveness to attract customers, is now moving towards an entirely different direction. Based on the McKinsey's projection of USD 1-1.5 billion of Indian clinical research business, even if 20% of trials adopt EDC by 2010, it is a huge market of USD 200-300 million
Cadila Pharmaceuticals Limited
SIRO Clinpharm Pvt. Ltd
MANIPAL ACUNOVA LTD
Asian Clinical Trials (ACT)