Quintiles opens Phase I unit in India

By Gareth Macdonald

- Last updated on GMT

Related tags: Clinical research, Hospital, Food and drug administration, Us

Contract Research Organisation (CRO) Quintiles has opened a Phase I facility in Hyderabad, India, citing increasing demand for efficiency in early-phase drug research in the country.

The INR400m (€6m) facility, which was set up in a 60/40 partnership with the Apollo Hospitals Group under a 2009 deal, houses 86 beds and will offer a range of bioavailability, bioequivalence and Thorough QT (TQT) services.

Quintiles had expected​ the unit to open in 2010 as a 50-bed facility but, as a spokeswoman told Outsourcing-Pharma.com, the extended time line reflected efforts to ensure operations were consistent with other Phase I units.

Our initial projections were based on our experience with construction projects in US and Europe. Wherever we work, we do so to the same high standards. In this case, our priority was to complete the building to our global standards, rather than pursuing an aggressive construction timeline​.”

She went on to explain that demand from pharmaceutical developers for efficiency in early clinical research was the primary motivation for development of the new site.

We have seen greater demand for Phase I studies in patient populations, as customers look to establish proof of concept as early as possible in the development process to help them make go/no go decisions sooner.”

Phase I investment

The new Hyderabad facility, located on Apollo’s “Health City” campus, is one of five Phase I centres that Quintiles operates at sites in the UK, Kansas in the US and in Lulea and Uppsala in Sweden.

It is also Quintiles’ second at a hospital behind its recently​ expanded research unit​ at Guy’s in London, UK which, according to the firm’s spokeswoman is scheduled for its grand opening later this year.

The [Guy’s] unit is positioned alongside leading-edge Clinical Research Facilities, a Good Manufacturing Practice (GMP) Pharmacy, and the home of one of five Comprehensive Biomedical Research centres in the UK​.”

Quintiles is not the only CRO to have set up a Phase I unit at a hospital in recent times. In December both Celerion​ and early-phase specialist Dedicated Phase I​ set up units at hospitals in the US.

Speaking to Outsourcing-pharma.com at the time Celerion's VP of clinical research said that, while hospital based Phase I units are common in Europe, increasing US Food and Drug Administration (FDA) pressure for certain types of medicine to be tested in a hospital environment is driving demand stateside.

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