US-based contract research organisation (CRO) Quintiles Transnational continues to extend the global reach of its central laboratories network, this time moving into the Japanese market through a tie-up with a local laboratory services provider.
Quintiles has announced an agreement with Medca Japan Laboratory Co. to provide central laboratory services from the latter’s facility in Saitama, a city in the Greater Tokyo area. Quintiles will have its own staff at the Medca Japan laboratory, which will support clinical trials in the domestic market.
Like the US company’s central laboratories in Singapore, Beijing (China) and Mumbai (India), the Medca laboratory is certified by the College of American Pathologists (CAP). CAP certification, which follows a site inspection, aims to improve patient safety by advancing the quality of pathology and laboratory services through education, standard-setting and ensuring laboratories meet or exceed regulatory requirements.
The CAP seal of approval should enable Quintiles to capitalise on a more liberal attitude in Japan to sourcing clinical data for approval applications from outside the national market.
“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,” commented Tom Wollman, senior vice president, Quintiles Global Central Laboratories.
“With CAP-certified labs in Beijing, Singapore, Mumbai and now Japan, we can provide well-controlled processes and harmonised testing services throughout the Asia-Pacific region to customers in Japan as well as our multinational customers.”
Medca Japan provides a broad range of laboratory services including biochemical, endocrine, tumour-marker, drug-level, immunology and microbiological testing. “We receive more than 30,000 specimens for examination per day, and this relationship will allow us to strengthen our clinical trial services while supporting continued growth of our existing laboratory operations,” said president Yutaka Kannari.
The relationship with Medca will be managed within Quintiles by Alan Ong, vice president and general manager, Quintiles Labs Asia, who will give technical guidance; and by Yoh Narimatsu, president of Quintiles Transnational Japan, who will supply local expertise.
