Clinical trials in India

Quest Diagnostics is one of the largest clinical diagnostic laboratories in the world. The company has bases in the US and UK , and provides a full range of testing and clinical trial laboratory services to pharmaceutical and biotechnology clients  across the world.

Quest Diagnostics performs central laboratory services; it offers comprehensive laboratory testing and data generation for companies conducting clinical trials. One of the company’s latest ventures is the setting up of a base in India for the provision of clinical trials services.

Why India?
Anthony J Santicerma, director of strategic alliances and global marketing with Quest Diagnostics Clinical Trials, believes India has many advantages for his company. ‘There are the cost benefits, since labour in India is cheaper,’ he says. ‘By having a base in India makes sense from a logistics point of view, as samples do not have to be sent to laboratories in the UK or US for analysis.

‘Furthermore, India has a highly professional workforce from which to draw personnel. More and more clinical trials are now being staged in India because as a country with a growing economy there is a higher prevalence of Western diseases, such as the metabolic syndrome disorders of diabetes, obesity, hypertension and arteriosclerosis.’

By expanding to India, Quest Diagnostics decided to establish its own laboratory and clinical testing base rather than using an affiliate company. The advantage in doing this is threefold, according to Santicerma.

‘First is the advantage of having more control and the ability to make marketing and business decisions to grow both the international core diagnostics business and the clinical trials business side by side,’ he says. ‘Secondly, the facility will provide a local laboratory to serve the entire region and will become a major hub for clinical laboratory services in Asia. Also, by being in the area, Quest will be in a position to attract more business from local contract research organisations [CROs].’

Another factor is the costs of bringing drugs to market, which is increasing all the time. ‘The cost of drug discovery and clinical trials are lower in India,’ adds Santicerma. ‘Estimates range from 30% to 70% lower than Western pharmaceutical companies. In the 1990s, little attention was paid to India because of limited protection for intellectual property, but now that it has more protection through the TRIPS-trade-related aspects of intellectual property rights, these cost benefits can be realised.’

India has a population of over a billion people, which provides many advantages, including the speed and ease of enrolment for clinical studies compared with countries such as the US. Studies can often be filled more quickly and at a lower cost per patient. It is also more likely that any patient joining a study will not have received prior treatment of any kind for their condition, which is now often a criterion in enrolment.

Expanding services
Quest Diagnostics provides comprehensive anatomic pathology (AP) services,
which is another area it expects to expand in India. The Indian office will help to increase the global network of AP laboratories and provide another offering of clinical trials services to CROs.

AP services will be provided under the central control of Quest’s main AP laboratory in Teterboro, New Jersey, US, which is headed by Dr Ronald Luff, a major contributor to the field of AP and developer of the Bethesda system. It is the expertise of the Teterboro laboratory that will drive the reputation of the global network of AP services, eventually linking with the new office in India.

The dynamic behind Quest moving into the Indian market and establishing a base is one of expansion rather than abandoning other markets in favour of India. India is currently an important and expanding market where many pharmaceutical companies either have or are going to have clinical trial activities.

Quest Diagnostics believes that having a substantial presence in India will win it a substantial proportion of the clinical trials laboratory support business and also give it an opportunity to make use of a less expensive but technically competent workforce.

Company profile
Quest Diagnostics Clinical Trials Inc provides global central laboratory services for clinical trials through proprietary facilities in North America and Europe, and affiliate facilities in Australia and South Africa.

For more information, visit www.questdiagnostics.com.

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