US-based contract research organisation (CRO) PRA International has built on what it describes as an “extensive” network of operations and partnerships in Asia by opening an office in Seoul, South Korea.
The company has been providing clinical trial management services in Sou
th Korea since 2005, mainly through local partnerships. However, increasing customer expectations and project needs called for a legal entity and a local team of clinical research professionals in the country, explained Edward Ian, director of clinical operations, PRA – Asia Pacific.
He sa
id PRA was expecting significant growth in its South Korean operations over the next few years, with clinical studies across a wide range of therapeutic categories including oncology, neurology, respiratory conditions and infectious diseases, as well as cardiovascular, endocrinology and metabolic di
sorders.
According to PRA, South Korea is widely regarded as the third most important pharmaceutical market in Asia and as one of the most important locations in the region for clinical trials to support new drug approvals. China, Japan and South Korea have made a joint statement of co-opera
tion on clinical research and Japan is now accepting South Korean trial data for Japanese registration, the CRO noted.
Moreover, the government of South Korea has demonstrated its commitment to establishing the country as a clinical research hub in Asia by forming KoNECT, the South Korea Nati
onal Enterprise for Clinical Trials. “The increasing volume of multinational clinical research taking place across all trial phases is indicative of the organisation’s success,” PRA commented.
Among the factors that attracted pharmaceutical companies to the region, it added, were:
<
br> – The quality of local clinical data
– “Progressive and efficient” regulatory and ethical systems, exemplified by the 30-day approval clock for investigational new drug applications and adherence to International Conference on Harmonisation standards of Good Clinical Practice
<
br> – The active engagement of “world-class” investigators
– Highly educated and committed clinical research professionals, including clinical research associates, study nurses, and study site personnel
– State-of-the-art trial facilities, including 124 sites accredited by the
Korean Food and Drug Administration and 12 regional clinical trial centres overseen by KoNECT
– Proximity to “vast” patient populations
“The addition of the South Korean office to our existing Asian network, together with our continuing plans for expansion across the Asian region, further enhances PRA International’s position as a CRO gateway to the world’s most dynamic and rapidly expanding clinical research environment,” said Susan Stansfield, the CRO’s executive vice president of product registration for Europe, Africa and Asia-Pacific.
