Quintiles gains central lab in Japan

The company has come to an arrangement with Medca Japan under which it will base its staff in its partner's laboratory in Saitama, Greater Tokyo, in order to better support the clinical trials that it is carrying out on behalf of its clients in the country. Medca provides a broad range of laboratory services, including biochemical tests as well as endocrine testing, tumor marker testing, drug-level testing, immunology testing and microbiological testing. Despite being the world's second largest drug market, Japan represents only 15 per cent of the total global spend on clinical development, having been largely held back by regulatory hurdles that have hampered the country's clinical industry. However, Japan is getting serious about clinical trial reform after years of lagging behind the rest of the developed world in the availability of drugs in the country and these hurdles are starting to be lowered by the Japanese regulators. One aspect of this is the loosening of the rules on where clinical trials for drugs sold on the Japanese market can be conducted. It is expected that in the next year or two sponsors will begin more regularly involving Japan in global studies from the start. "Recent changes in legislation are allowing Japanese pharmaceutical companies to extend clinical trials normally conducted in Japan to other countries in Asia, but these companies have had difficulty finding central lab services that are harmonized throughout the region​", said Tom Wollman, senior vice president of Quintiles Global Central Laboratories. The new Japanese lab adds to the central laboratory operations that Quintiles is already running in the nearby Asian countries of Beijing, Singapore and Mumbai, all of which have been certified by the College of American Pathologists (CAP). "This lab, along with all labs in our network, will follow the same standard operating procedures, and data will be available on our QNET database​", said Wollman. Quintiles has been busying itself in the Asia-Pacific of late, an area that is witnessing a period of growth in the demand for clinical trials services as the pharmaceutical industry continues to globalise in search of time and cost efficiencies in drug development and access to new untapped markets in which to sell their drug products. Only two months ago Quintiles announced the consolidation of its Global Central Laboratories and Clinical Development Services (CDS) units in Beijing into a single, but expanded facility in order to accommodate its growing business in China, as well as improve coordination and efficiency. The laboratory currently has 13 employees but this number is expected to swell to 60 within the next year. "Quintiles' business is growing at a significant rate, and our larger facility will allow us to efficiently accommodate both the growth and our expanding test menu, which have moved well beyond basic safety testing to include specialised chemistry, PCR testing and complex flow cytometry​", said Wollman.