Recognizing the growing potential for drug development in Southeast Asia, especially Japan, PRA International has entered into a strategic collaboration with two contract research organizations (CROs) in that region.
The Raleigh, N.C.-based CRO has partnered with LSK Global Pharma Services in South Korea and Mediscience Planning (MPI) in Japan to expand PRA’s ability to serve clients in Asia.
“This partnership will further improve our ability to promote and execute regional clinical trials in Japan, Taiwan and Korea,” said Edward Ian, senior director of clinical operations for PRA-Asia Pacific.
PRA began conducting work in the Asia-Pacific region in 1997, with operations in Australia and New Zealand, and expanded to Southeast Asia in 2004. At that time, the company’s regional efforts were focused primarily on Singapore, Hong Kong and Taiwan.
“We really didn’t know much about operations in Korea, the regulatory process requirements, the IRB or ethics committees’ timeline …However, we had a lot of requests for Korea,” Ian said.
PRA launched an extensive search of Korean CROs before landing on LSK as a possible partner in 2005. The companies joined forces later that year but have been fine-tuning the relationship through training and knowledge-sharing for the past four years.
“I really hate to use the word ‘subcontractor’ because our relationship with LSK is more than a supplier-customer relationship. It’s really evolved into a partnership-type of relationship,” Ian said. “[LSK] has evolved from being a local CRO working only on local studies to one that is really able to work on global studies.”
In 2006, PRA decided to expand its services into Japan and began talks with Japanese CRO MPI. At that time, most of PRA’s Japan-related work was for Japanese pharmaceutical companies operating on a global scale. Today, thanks to the recent collaboration of PRA, LSK and MPI, PRA can offer both local and global clinical trial management for Japanese pharmaceutical companies.
“It really depends on the needs of the Japanese pharma. If they need a clinical program to be done in three countries only—Japan, Korea and Taiwan—that’s great. If they have needs to take the projects to China or Singapore, then PRA’s regional help in Asia-Pacific will be able to come in,” Ian said. “It’s a global level of clinical trial management services for those Japanese companies that may have more than regional study needs.”
With LSK’s help (and subleased space), PRA plans to open its South Korean affiliate, PRAKorea, by the end of March. The company has other affiliate offices in China, Taiwan, Australia and India, and according to Ian, plans to expand its presence in the Asia-Pacific region in the coming years.