Over the last 10 years, South Korea has increasingly become a global clinical trial (CT) hub and has established itself as one of the leading CT destinations in the Asia region. In 2015, South Korea approved a total of 675 trials from South Korean and multinational drug makers for early phase studies that would lead up to Ph III trials – this includes: Ph I and Ph II – in comparison to 652 in 20141. Further, data collected from clinicaltrials.gov reported a total of 243 (179 in Ph III and 64 in IV) interventional studies approved in 2015. This is predominantly due efforts by the South Korean government to promote the CT environment with attractive incentives and facilities that encourage international clinical trials.

When compared to other countries in its vicinity, South Korea has many advantages. It is less complex and costly to conduct a clinical trial compared to Japan, and quicker to start up than China. In addition South Korean investigators receive high quality training, and work to international good clinical practice standards as well as local government accreditation standards. Investigators are typically supported by experienced teams of research coordinators who help the trial run smoothly.

The many examples of efforts put in place to maintain South Korea’s high-quality CT services include the South Korean Ministry of Food and Drug Safety (MFDS) implementing a 40 hour mandatory training program for new clinical research associates (CRA) which is then followed by 8 hours per annum of training. Furthermore, the support of South Korean government entities – such as the Korea National Enterprise for Clinical Trials (KoNECT) – has greatly advanced CT infrastructure development by promoting South Korea’s clinical trial capabilities on a global scale.

Recognizing that South Korea is a critical country for international trials in the region, George Clinical recently established their own legal entity in South Korea. Although George Clinical has worked in South Korea for a number of years through a partnership model, its own resources on the ground is vital for adequate oversight of trials, and to allow George Clinical to act as a Sponsor for customers who do not have local affiliates in South Korea.

George Clinical also recently exhibited at the largest bio exhibition in Asia – BioKorea 2016, held in Seoul, in order to better understand the South Korean biopharmaceutical market. The growing maturity of South Korea’s biopharmaceutical market is well recognized, and George Clinical exhibited under the Australian Pavilion which was sponsored by The Australian Trade and Investment Commission (Austrade) with a number of other Australian organisations. A seminar on Australia’s clinical trial capability was organized by Austrade, where Dr Marisa Petersen – George Clinical’s Chief Executive Officer – was invited to speak on the topic of Australia and the International Clinical Trial Environment. Dr Petersen touched on the diversity within the Asia-Pacific region and how Australia can play a leadership role across pan-Asia studies, particular when designing and managing Phase II – IV trials.

With a large population at 50 million, a strong economy and advanced medical infrastructure, South Korea is an attractive market for CTs. Its major advantage is also reinforced by the transparency, quality and patient availability in the country. With an entity in South Korea, George Clinical is now better able to deliver clinical trials of high standards for its customers in the country.