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Saturday, February 25, 2006

Analytics outsourcing - emerging models in India

The Indian Industry has witnessed a growth in the amount of Clinical Trial Data over the last decade. The success of the IT industry in India has instilled confidence amongst CROs and the Pharma companies to venture into various models of data management outsourcing. Some CROs have created data management infrastructure to provide a basket of services as a preferred full-service provider including clinical trial and data management.

Big CROs offer their Indian counterparts to use their global server, software and other infrastructure with addition of user licenses to extend their data management business. Hence they can have cost-saving on few hardware and software to start the data mangement business. These CROs also offer stand-alone data management services.

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 Mangement 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 provdes the office and manpower both. This model promises the vendor to act as a Functional Service Provider (FSP) on project / protocol basis after certain pre-decided years.

This model demands a lot of initial investment and provides an opportunity for the local service provider to learn tricks of the data management business besides promisiing a lot of future core business as an outsourcing partner. Main competitors in this kind of business models are the local CROs and ITES companies who plan to diversify into data mangement segment.

With India emerging as IT superpower and Clinical Trial Hub, outsourcing to India for Clinical Data Management is more obvious than predicted. The Indian Industry, which earlier relied on its cost effectiveness to attract customers, is now moving towards an entirely different direction. Quality and fast response are the new buzzwords to dominate the business processes which ensure accurate, reliable services to the customers. While several models of businesses are emerging, only results will tell how many of them are attaining fast break-even after meeting stringent global regulatory standards. The time will test the success of experimentation of each of these players, who cross the critical path with proactive risk mangement approach in this world of innovations and new technology. The layers meeting the industry expectations of increased adoption of global standards, regulatory compliances and pressures of cost and cycle time reductions in drug development, with an efficient and effective data mangement system will survive.

The author is a career Venture Capital consultant for early / late stage enterprises specialising in Analytics Outsourcing / Clinical Trial Ventures and can be contacted thro email kmonyb at gmail dot com.


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