Meeting local standards while ensuring global quality and harmonisation has resulted in “huge growth” at the site in Japan, according to Alan Ong, vice president and general manager, Quintiles Global Central Laboratories Asia, and this has driven need for more capacity.
Quintiles is gaining this capacity by moving its laboratory from Saitama to Tokyo. Ong explained to Outsourcing-Pharma that the site at Saitama was held back by space constraints and difficulties harmonising testing platforms to increasingly exacting standards.
At the Tokyo site an area three times the size of Quintiles’ share of the Saitama laboratory, which is owned by Medca Japan, has been earmarked. Quintiles has begun moving activities to the new wholly owned site and anticipates the majority of studies will be transferred by the fourth quarter.
The Tokyo site will initially focus on safety testing with additional services being added in response to demand and to harmonise the laboratory with the rest of the network, Tom Wollman, SVP of Global Central Laboratories at Quintiles told Outsourcing-Pharma.
Steps are being taken to gain certification by the College of American Pathologists (CAP) at the Tokyo site. Ong explained that it is difficult to put an exact timeline on this process but Quintiles is aiming to gain accreditation by the third quarter.
An application will be filed by next month, after which CAP will give a definite scheduled date, and Ong is confident the site will be accredited. This belief is underpinned by Quintiles’ experience of working to the CAP quality system.
The Tokyo site has already received National Glycohemoglobin Standardization Program Level 1 certification for diabetes testing.
Quintiles’ Tokyo site began receiving clinical trial samples on March 1 and Ong said a number of new studies have begun at the laboratory. Discussions with sponsors are underway to switch Saitama studies to Tokyo, although those finishing this year will remain at the old site.
Furthermore, sponsors can request that studies remain at Saitama. Medca will operate the whole of the Saitama site, having also been space-constrained, and will remain as Quintiles’ third-party reference laboratory partner.