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Clinical research outsourcing: Emerging models

Dr Umakanta Sahoo

The Indian industry, which earlier relied on its cost effectiveness to attract customers, is now moving towards an entirely different direction—quality and quick response, says Dr Umakant Sahoo in the concluding part of the article

The Indian industry has witnessed a growth in the amount of clinical trial data over the last decade. The success of the information technology (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. 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 management 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 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 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 promising a lot of future core business as an outsourcing partner. Main competitors in this kind of business models are the local CROs and IT-enabled services (ITES) companies who plan to diversify into data management segment.

Competition

As of today, India has witnessed different types of players venturing into the clinical trial data management business, some of them are full-fledged CROs starting separate data management units, some of them are IT/ITES companies diversifying to data management business and some are pharmaceutical companies setting up biometrics and data management operations solely on their own or through partnership, and some are entrepreneurs not related pharma or CRO or IT business, but joining the fray looking at the prospects of the business.

CROs

Quintiles in Bangalore is expanding the data management team by moving work to India and has hired 187 people in data management. SIRO Clinpharm has a full-fledged data management unit and is also working with Pfizer on a retained FTE model providing contract staffing operations. ICON Clinical Research has acquired a Chennai-based Biomines Research Solutions which will focus on data management and biometrics services. Bangalore-based Pharmanet’s (now SFBC International) has an operational data management and biostatistics unit which is handling a lot of clinical data management work in co-ordination with their UK and European office. Mumbai-based clinical research organisations like Asian Clinical Trial, ClinInvent, DnO, have invested on oracle clinical software to provide data management services to global pharma companies. Acunova, an off-shoot of Manipal group of hospitals has expertise in bioinformatics and medical software and offers clinical data management and biostatistics services to pharma companies, besides the site management and contrac research capabilities.

Synchron, a local CRO offers complete clinical data management services for data processing, analysis and management from their Bangalore facilities. Besides this, many clinical CROs including Covance, Parexel, Chiltern, PRA International, MDS, Lambda, etc are exploring the possibility of setting up clinical trial data management and biostatistics in India. Some CROs are hiring resources in areas like biostatistics, SAS programming and other IT enabled services to work from Indian remote locations to support their active data management units.

IT-pharma ventures

Further IT/ITES companies like Accenture, Wipro, Intel, Satyam, Cognizant, IBM, Oracle and TCS have ventured into offering bio-IT initiatives in India. While some of them have actively started the clinical data management initiatives, others are planning to venture in IT solutions, installation and implementation, training and familiarisation supports. For example, Pfizer, India has signed a preferred provider contract for its Biometrics Division with Cognizant Technologies, India seeking data capture, data management, statistics services for its phase I, II, III global trials.

Similarly, Accenture is working exclusively for Wyeth in clinical trial data management with a strength of approximately 400 people, having two offices and plans to open third one. GSK’s biomedical data sciences India and clinical data management center at Bangalore supports 36 studies for GSK worldwide with its 64 people on roll (can accommodate 120).

Other IT/ITES companies’ bio-initiatives

IBM Life Science solutions aims to provide the IT infrastructure that researchers in biotechnology, pharmaceutical research, genomics, proteomics, and healthcare need to turn data into scientific discovery and new treatments for disease. IBM is also offering installation, validation and training support for clinical data management unit in India.

Advanced Technology Center (ATC) of Tata Consultancy Services (TCS) in Hyderabad, in collaboration with the Council for Scientific and Industrial Research (CSIR) and supported by the Department of Biotechnology (DBT) aims to offer end-to-end solutions, services and products to life sciences and healthcare institutions worldwide.

Another IT giant, Infosys has a life science division and they do claim to be involved global contract research. Besides, Infosys is partnering with Oracle India to provide installation, validation and training for Oracle clinical software.

Satyam Computers in collaborations with Centre for Cellular and Molecular Biology (CCMB, Hyderabad) develops software tools for genetic testing and provides manpower services, pharma-cum-database value added services to pharma and biotech companies.

Wipro Healthcare’s Life Science division claims to offer pharma companies IT solutions that will reduce drug discovery and approval time. Sakti Group, a New York and Bangalore-based company is also doing data management and statistics work. Besides, this every small and big software companies are developing a package/software for clinical trial management, project management, documentation management, approaching small CROs, pharma companies, etc.

Conclusion

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 buzzword 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 global stringent regulatory standards. The time will test the success of experimentations of each of these players, who cross the critical path with proactive risk management approach in this world of innovations and new technology. The players meeting the industry expectations of icreased adoption of global standards, regulatory compliances and the pressures of cost and cycle time reductions in drug development, with an efficient and effective data management system will survive.

Dr Umakanta Sahoo is General Manager, Chiltern International Pvt Ltd, India. E-mail: umakanta.sahoo@chiltern.com