South Korea is one of the most advanced countries regarding clinical research. According to data from the National Institute of Health (NIH)’s ClinicalTrials.gov, Korea ranked sixth in the number of clinical trials conducted last year. Seoul, the nation’s capital, topped the list with the most clinical trials in a city.
In reality, however, most of the clinical studies in Korea are still led by multinational contract research organizations (CROs). People have prejudices in Korea that foreign CROs will be more helpful in conducting global clinical research or entering an overseas market than local ones.
However, Korean CROs which have grown with the advancement of the clinical trials market are superb in their services, compared to international peers.
LSK Global PS, one of the leading local CROs, offers a full-range quality service for clinical studies, with accumulated experiences in data management, and statistical analysis.
Lee Young-jack, founder and CEO of LSK Global PS, is a leading clinical trial expert and statistician in Korea.
He built his career working as a statistician for the U.S. National Cancer Institute, the U.S. National Institute of Neurological Disorders and Stroke, and the U.S. National Institute of Child Health and Human Development. Based on his expertise, Lee founded LSK Global PS in 2000.
Question: What kind of services does LSK Global PS offer?
Answer: LSK Global PS not only provides services for clinical research in all stages from phase 1 to phase 3 but delivers services for regulatory approval. Available with all the necessary platforms for global clinical trials, the company offers a customized service based on the needs of a client.
Q: It is becoming more important to manage adverse drug reactions during clinical trials. It is an area that requires a control system that meets international regulations. How do you manage pharmacovigilance?
A: LSK Global PS has a globally-competitive pharmacovigilance system. So, we’re very thoroughly managing adverse drug reactions. In November last year, we upgraded providing pharmacovigilance services in line with the European Medicines Agency (EMA)’s guidelines for the management of clinical safety information (Eudravigilance) and data elements of ICSR (Individual Case Safety Report) (E2B(R3)).
Q: Data management must be really important in clinical trials. How does LSK Global PS perform in this area?
A: When I worked in the U.S., I had a hard time dealing with data management. In clinical trials, good quality data is so important, so I’ve made a lot of investment and put much effort in this area.
LSK Global PS has about 80 employees in the data management (DM) team alone. We have 40 statistics and epidemiology specialists and 10 medical writing personnel. It will be hard to find a local drugmaker with such big team for data management.
Above all, LSK Global PS's strongest points include a global competitiveness in data management, fast communication, and reasonable cost.
In the area of data management, our company offers three internationally verified systems such as Target Health, Medidata Rave, and Oracle InForm. This makes us offer services according to the needs of pharmaceutical companies.
In addition, our company’s clinical operation and data management of clinical trials have an excellent quality that can be submitted to the U.S. Food and Drug Administration at any time.
Q: Can you tell us how your company performed to win orders for multinational drugmakers' clinical trials?
A: I cannot elaborate in detail but we have provided many clinical trials of many “famous” global drugmakers. Since I established the company (in 2000), we have conducted 115 global clinical trials. In 2010, we competed against a foreign CRO and won to sign a contract for “First in Human” clinical trials. This was possible because we were competitive enough.
Q: Why should pharmaceutical companies choose LSK Global PS as a partner in clinical trials?
A: In conducting clinical trials, it is important to ensure promptness and quality. Observing the rules and keeping the protocol is the way to ensure quality. LSK Global PS is a CRO that not only has professionals but also can communicate quickly and provide quality results. LSK Global PS can confidently say that it is the best partner with global capabilities. Choosing LSK will be choosing the best partner in clinical trials.
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