US-based biopharmaceutical services company Quintiles has officially opened its Phase I research facility at Apollo Health City in Hyderabad, India.
Quintiles announced in early 2009 that it had formed a partnership with Apollo Hospitals Group, the largest private hospital company in India, to set up the Phase I unit in Hyderabad, with combined investment expected to be around US$6 million. The facility was originally scheduled to open in the first quarter of 2010.
According to local reports, total investment in the initiative was 400 million rupees, which would be in the region of US$8.9 million. Quintiles Phase One Clinical Trials India Private Limited is a 60:40 joint venture between Quintiles and Apollo Hospitals, with Quintiles holding the larger stake.
The 86-bed unit will be used to evaluate compounds developed both in India and other countries. Thirty-two of the beds are equipped with technically advanced diagnostic cardiology equipment for Thorough QT (TQT) studies in cases where there may be cardiac safety issues.
Quintiles said the new facility would complement its existing Phase I units around the world, “to help customers navigate complex early development challenges and make key decisions early”.
The Indian facility would give biopharmaceutical clients “additional options to complete integrated Phase I programmes across multiple geographies at this pivotal stage in medical research”, it added.
Accordingly, data capture at the new site will be linked electronically to Quintiles’ other Phase I units in London (UK), Kansas (US) and Uppsala (Sweden), “to simplify study management for sponsors and provide integrated information and perspective as early as possible in the development process”.
Clinical trial sponsors “are under intense pressure to speed delivery of results, ethically, and without compromising patient safety or quality of data,” commented Eddie Caffrey, senior vice president and head of Quintiles Phase I worldwide.
“With this new, state-of-the-art, Phase I facility in Hyderabad, India, we will be better able to ally with customers by providing access to large numbers of healthy volunteers for simple studies, in parallel to more complex studies conducted by scientific experts in Europe and the US.”
The Hyderabad team will work to global standards and procedures under executive director Ashish Jain, Quintiles noted.
The company already has offices in Ahmedabad, Bangalore, Delhi, and Mumbai, India, covering a broad range of therapeutic areas including oncology, central nervous system conditions, infectious diseases and cardiovascular disease.