Globally, the clinical trials business is experimenting with several innovative initiatives to reduce cost and time without compromising on quality. Noteworthy initiatives in this regard include diversifying the clinical trial business to cost effective destinations such as Eastern Europe, India and China, using the new and modern technologies such as remote data entry (RDE), and electronic data capture (EDC). Hence, a growing number of trials are being outsourced to India and other developing economies. They have become important centres for global multi-centric trials, particularly with regard to patient recruitment. Since most of these trials are originating from USA and Europe, the technology, systems and processes are also driven from there.

Until now, these trials had been focused around the traditional paper based approach. However, due to time and cost pressures, there is a global change in the perspective of clinical data management. According to Pricewaterhouse Coopers (PWC), the shift from paper-intensive approach to paperless Internet-enabled clinical trials will bring a 30 to 50 per cent reduction in development time and cost. Hence, sponsoring biopharmaceutical companies are exploring the use of advanced electronic data capture globally for all sites to achieve consistency, efficiency and quality of data.

It appears that there is a possibility of a changed perspective for clinical data management in India even though many players still believe in leveraging the low cost advantage of manpower and technology.

Current data management business models

The success of the IT industry in India has instilled confidence amongst contract research organisations (CROs) and the pharmaceutical companies to venture into various models of data management outsourcing. The current data management business models evolve around the traditional method of collection of completed case record form (CRF), creation of database and input screen, implementation of single / double data entry methods, quality control and database luck involving a huge human resources (data entry operators, data validation associate, data manager, QA /QC manager), costly and sophisticated hardware and software. This is considered to be a huge capital and labour intensive business requiring considerable detail at each step.

Another model that is becoming popular for a few selected pharma companies in India is the retained Full Time Equivalent (FTE) Model. In this model, the pharma companies outsource the job of developing the facility, offices and human resources (FTEs) [Statistical Programmer, Statistician, Data Viewer, DB Designer and Medical Writer] to a service provider, who could be a CRO or an IT company with the understanding of the clinical trial data management and biostatistics business. The pharma companies provide hardware, software and arrange for their installation and training. This model is essentially an extension to the contract staffing model as the service provider provides both the office and manpower. This model promises the vendor to act as a Functional Service Provider (FSP) on project/protocol basis after a certain number of pre-decided years. This model demands a lot of initial investment and provides an opportunity for the local service provider to learn the tricks of the data management business besides promising a lot of future core business as an outsourcing partner. Main competitors in this kind of business models are the local CROs and the IT / ITES companies who plan to diversify into the data management segment.

Key players

As of today, India has witnessed different types of players venturing into the traditional method of the data management business. Some of them are full fledged CROs starting separate data management units, some of them are IT / ITES companies planning to support the data management business in terms of providing data management solutions and some are pharmaceutical companies setting up biometrics and data management operations solely on their own or through partnership. Others are entrepreneurs not related pharma or CRO or IT business, but joining the fray looking at the prospects of the business.

Table - I: Clinical Data Management Players

CROs	Pharma Companies	IT / ITES Companies
Quintiles	Pfizer	Accenture
SIRO ClinPharm	GSK	Wipro
ICON	Novartis	Intel
Pharmanet	Wyeth	Satyam
Synchron	Astra Zeneca	Cognizant
Acunova		IBM
DnO		Oracle
ClinInvent		TCS
		Infosys
		Sakti Group
		Sristek

While Pfizer has their own data management unit, they are also using the FTE and FSP model and using the services of SIRO ClinPharm and Cognizant for their data management initiatives. Other local and global pharma companies in India either have their own data management unit or outsource locally to a CRO or other local service provider for full or part of their data management and statistical analysis related tasks.

Changing perspective

Globally, 80-90% of the clinical data management uses the traditional method of paper-based approach and barely 10-20% of the clinical trials use EDC. But, the trend may reverse in next few years. In recent years, the bio-pharmaceutical players have shown interest in moving away from the inefficiencies of the paper-based processes to adopt the EDC system, a "paperless approach," to be competent in clinical research. Thomson CenterWatch estimates that with an annual compound growth rate of 21%, the EDC market size reached US$ 205 million in 2004. But with the current EDC focus of many global biopharmaceutical players and contract research organisations (CRO), this market may grow up to US$ 1 billion dollar by 2010.

Chart 1: EDC Market Size (US$ Million)

Source: Thomson CenterWatch Publication, Vol. 12, Issue 2, Feb 2005

According to another estimate of CenterWatch, 30-40% of the phase II and III studies in 2004 started adopting EDC, although this growth will be more than double in four years.

EDC prospects

Today, there are more than 100 vendors who directly or indirectly are associated with EDC. They play different kinds of roles, such as starting from providing branded EDC solutions, supporting in implementation and training, creating project specific EDC solutions.

Table - 2: EDC Promoters

EDC Vendors		CROs	Pharma Companies
E-Trials	ClinPhone	Quintiles	Pfizer
Phase Forward	ClinTran	Parexel	Eli Lilly
DataTrak	Datafax	Chiltern	GSK
Oracle	Trakware	Cato Research	Novartis
Trial Master	Penergy	Octagon	Wyeth
Medidata Solutions	Trial Tracker	Scirex	Schering Plough
MetaTrial	Datalabs
Quest	Site Base

Source: Media News

Some of the EDC Promoters, especially the CROs and pharma companies, are active in carrying out clinical trials in India. Global companies such as Pfizer, Eli Lily, GSK, Novartis, Wyeth, Quintiles and Chiltern have their presence in India and they are running multi-centric phase II-IV trials at Indian sites. While all of them are carrying out paper-CRF based clinical trials, a few players such as Quintiles and Pfizer have started undertaking EDC trials as a part of the global contract and deliverables.

Most of the clinical trial businesses outsourced to India are driven by global sponsors. Hence, if the global data management trends move from the traditional paper based method to electronic data capture methods, India will follow suit. Considering this, many CROs, who are planning to expand to data management operations, are now in a dilemma; whether to invest in data management or advance immediately to EDC. As they understand it, EDC is the next most commercially sensible decision for the global sponsors and it may defunct some portion of the data management business, especially the most time consuming data entry and query resolution process.

But, there are a few CROs and pharma companies, who strongly believe that if clinical trials are to be done in India, these should to be traditional paper based, rather than EDC, to take advantage of low cost of labour. They are comfortable setting up data management facilities in India as they feel that the country has the resources to meet the quick and quality data entry and data management tasks. They feel strongly that although India has overall strengths in IT and IT enabled services, it will take at least 5 years for the hospitals and clinics to equip themselves with global standard infrastructures in areas such as hardware, software, and high speed internet connectivity for data transfer.

But it is seen that an increasing number of global contracts are being diverted to India to cover up the shortfall in recruitment where the pharmaceutical companies have already using EDC elsewhere. Hence these companies do not mind a little additional investment to equip Indian sites with EDC infrastructure and the investigators with adequate training, as they feel they are going to save a lot of money and time by fast recruitment possibilities.
Looking at this trend, many local pharma companies and contract research organizations in India are attempting to partner with EDC vendors to convert them from paper to electronic to adopt this web-based technology and remain competitive in this field. Some Indian CROs have also initiated developing their own systems in-house to become eCROs. Based on the McKinsey's projection of US$ 1-1.5 billion of Indian clinical research business, even if we assume 20% of trials adopt EDC by 2010, it is a huge market of US$ 200-300 million. Hence, it is apparent that India will witness rapid growth of EDC trials.

EDC vendors are actively looking at India as a market for their products. But they are aware that the global sponsors in USA and Europe will decide the EDC systems to be used in India and other growing regions. Looking at the prospects of the EDC, many local IT vendors are also planning to develop and market integrated clinical trial management and EDC systems to Indian pharma companies and CROs.

In short, technology alone cannot confer the benefits of EDC. The success of the changing paradigm of EDC depends on the skilful training and thorough implementation. Users must be trained in redefined processes and software functionality. They should adhere to the highest practical security standards, as governed by regulatory or governmental requirements, including the regulations relating to electronic records and signatures (e.g. FDA 21 CFR Part 11) and data protection.

Sponsors/CROs should contract an EDC vendor who understands the requirements and concerns of the clinical trial and in-turn should design the database, configure and validate the system. The EDC vendors should provide thorough training to monitors, investigators, study coordinators and other relevant users of the EDC systems. Besides training, the EDC vendors should offer 24 by 7 hours helpline and support capabilities through the availability of highly skilled and responsive staff with multilingual capability for online troubleshooting and query resolution at all the sites. The sponsors and CROs should also play a major role in guiding the process, evaluating vendors, implementing technology, training personnel, tracking performance and making sure that EDC transitions are implemented effectively.

(The author is general manager, Chiltern International Private Limited)