Capitalizing clinical research in India

Quintiles India, a subsidiary of Quintiles Transnational, clocked an annual sales revenue of Rs 375 crore in FY 2009-10 with an Indian market share of almost 50 percent. It offers an integrated services for phase I-IV studies to global biopharmaceutical companies.

Quintiles is building a phase I center in Hyderabad in collaboration with Apollo Hospital. The new center will be operational by October 2010. It will be the fourth phase I center for Quintiles globally. The company is a full service contract research organization (CRO) offering the complete range of services and has conducted over 275 global studies, with more than 46,000 patients recruited since 1997.

Since its inception, Quintiles India has been involved in global clinical trials for customers in the US, Europe and Japan and this data has been used in global regulatory submissions successfully.

Quintiles Data Management (DM) Center in Bangalore has more than 440 personnel and is the largest DM center of Quintiles. This unit has been involved in over 600 global studies of processing more than 1.5 crore pages.

The CRO also offers biostatistical services from its Bangalore center. Cardiac Safety Laboratory services is offered from its Mumbai and Bangalore. The ISO 9001:2008 certified lab of Quintiles has a capacity to analyze 400,000 ECGs a year. It provides digital ECG analytical services (including Thorough QT (TQT) studies) to sites in any corner of the globe through its strategically located project managers. Till date, this lab has processed 12 lakh ECGs across more than 750 global studies.

In India, Quintiles has a strong pharmacovigilance service offering with more than 220 full-time employees. Having a capacity to process approximately 9,000 cases every month, this service line has processed more than 125,000 cases till date for global and regional studies.

The US FDA has inspected nine sites in India and five of them are Quintiles-managed studies, the highest number for any CRO in India. In addition to this, Quintiles sites and facilities have been audited by customers or independent auditors and there has been no critical findings reported.

Cenduit, a leading Interactive Response Technology (IRT) solutions provider, is a 50:50 joint venture company between Quintiles and Thermo Fisher. With over 150 employees globally (of which 100 are based in Bangalore) and head quartered at Raleigh, US, Cenduit provides delivery and customer support from its Bangalore office.

Quintiles is a 33 percent joint venture partner in Invida, a leading pharmaceutical commercialization services company having operations in 13 countries and employing more than 4,000 people across Asia. In India, Invida has more than 1,100 full-time employees spread across the country.