Getting to know the locals

BEIJING—Quintiles, in keeping with the industry's growinginterest in the Asian pharmaceutical market and the company's own history inthe area, recently announced that it would be launching Kun Tuo, a localcontract research organization (CRO) in China. The CRO will cater to the needsof the Chinese biopharmaceutical industry and also provide another outlet forQuintiles' services in the area.

"Kun Tuo will leverage Quintiles' quality and trainingsystems to offer customized, high-quality solutions best suited for localChinese biopharma, as well as global biopharma local affiliates," Ling Zhen,general manager of Quintiles China, said in a press release. "We have anaggressive growth plan for China and anticipate doubling Quintiles' total staffduring 2012 as we look to provide our customers with the solutions they need tosucceed in one of the world's most dynamic marketplaces."

The venture is far from the company's first foray into thearea. Quintiles China has operated in China since 1997, and today has more than300 employees at its population centers and study sites. The company currentlyhas facilities in Beijing, Shanghai and Hong Kong, including a centrallaboratory in Beijing. In addition, Quintiles has routinely emerged as a leaderin the region, having been named Best Asia Pacific by Frost & Sullivan in2009, 2010 and 2011; Best Central Lab in China by the Shanghai Medical HealthCenter in 2009; and Best CRO by Biopharma Asia 2011.

Zhen says that since its inception in China, Quintiles hasfocused mainly on the global trial market rather than the local market. Inrecent years, however, he says the company became increasingly aware of thegrowing demand from local domestic pharmaceutical companies for CRO services inChina. While Quintiles attempted to establish a position in the local drugmarket segment using the team and infrastructure it already had in China, it wasnot very effective, Zhen says.

"We decided to launch a separate CRO with a different brandname, a different operating mechanism, with a different set of SOPs,specifically to work out local trials," he says.

Kun Tuo will be a full-service CRO offering services tocover clinical research from Phases I to IV, including comprehensive clinicaltrial management, data management, regulatory submission preparation andbiostatistics. The CRO will draw on Quintiles' already established globalresources, experience and relationships to offer services in key therapeuticareas, as well as late-phase studies, medical devices, diagnostics andvaccines.

Quintiles noted in a statement that "more comprehensiveclinical research services, such as clinical supervision, project management,research center management (clinical research assistance), data management andbiometrics, medical and scientific services and registration services will beintroduced to the Chinese market in the future."

"This CRO, Kun Tuo, will nicely complement what we have inChina already, from Quintiles' perspective," says Zhen. "Quintiles started inChina very early, and we have built up a very nice infrastructure and operatingprocedure … we have built up a nice resource network with the regulatorybodies, with the local doctors, with the local hospitals, and we have been adominant player in the global trial market segment. And there, with the launchof Kun Tuo, the local CRO, is really to leverage some of the resources, theinfrastructure, the relationship with the regulatory bodies … to jumpstart thislocal solution-delivery team. Then our plan is to make Kun Tuo the leadingservice provider in the local trial market segment within the next year."

Zhen notes that Kun Tuo will rely on a local facility to betheir preferred lab, and says the companies have already seen a great deal ofinterest from their customers in China.

"We have pretty much everything we need to tackle the localmarket," says Zhen.

In addition, Quintiles has also recently announced theopening of a business process outsourcing and project management center ofexcellence in Dalian, a major city in northeast China. The new facility willoffer data management, pharmacovigilance, biostatistics, medical writing,post-marketing safety surveillance and back-office support for administrativefunctions for global and local companies, in addition to supporting clinicaloperations in study sites in the region. Quintiles expects to expand thecenter's staff to 500 employees over the next several years once all servicesare established.