Services Galore at Quintiles

Quintiles Spectral (India) is a subsidiary of Quintiles Transnational, the world's leading provider of information, technology and services to the healthcare industry. Quintiles India brings together quality, speed and low cost through client-centered project management, trained clinical and regulatory staff and a dedicated facility for clinical trial supplies storage. It provides high quality across all trials through the use of globally accepted SOP's and ICH GCP standards. The Indian government has approved Quintiles India as a commercial R&D company, an important designation that recognizes the company's contributions to the drug research industry and its status among pharmaceutical service organizations in the country.

Quintiles India offers high quality clinical data management services for Phase I, II, III and IV studies in various therapeutic areas. It has been utilizing India's IT expertise to assemble a data management team in Bangalore that is trained and skilled in offering data management services in Clintrial, Oracle Clinical and various EDC platforms. The unit provides customized solutions to pharmaceutical, biotech and medical devices companies, including CRF design, database design, query management, double data entry, coding and quality control as per the global standards and at highly competitive prices. Besides, it also offers services in the areas of project management, clinical trial monitoring, regulatory affairs, drug safety, protocol development, site management, quality assurance, clinical trial supplies, data management, training and centralized ECG.

Quintiles India has done studies in cardiovascular, endocrinology, infectious diseases/internal medicine, oncology and other therapeutics areas. Significantly, it has completed a diabetes study for a European sponsor and has further won three more studies from the same sponsor. It has also conducted pivotal studies on bipolar disorder and the drug has been approved based on its data. Having completed one study on Parkinson's disease, Quintiles India is presently working on two other trials on the same disease. It has also undertaken study in chronic spinal cord injury under a US FDA fast track approval. The company has done parasitology trials, bacterial keratitis studies and a large anti-diarrheal study for its European clients. Pivotal Phase III study in bacterial conjunctivitis was completed and the drug was approved by USFDA based on the Indian data.

The company has expertise in conducting oncology clinical trials also. It has completed about 19 oncology studies, as part of multi-country programs for regulatory submissions.

Quintiles India currently has offices in Ahmedabad, Mumbai and Bangalore. It has experience in working on over 90 clinical studies involving more than 600 sites and 13,000 patients including studies in oncology, psychiatry, neurology, anti-infectives, gastroenterology, ophthalmology, endocrinology and cardiology. It has upgraded facilities at many hospitals and provided GCP training for the investigators. In 2003-04, its revenue has increased to Rs 62.55 crore against last year's figure of Rs 38.4 crore.