LSK Global PS

LSK Global Pharma Services Co., Ltd.(http://www.lskglobal.com/), established in 2000 in Korea, is the nation's largest integrated contract research organization (CRO) that has provided therapeutic area-specific services across oncology, cardiovascular disease and endocrinology. LSK Global PS is a full-service CRO encompassing all of the major areas of clinical research, including clinical trials from phase I to IV, investigator-led clinical studies, PMS (post-marketing surveillance) studies, safety studies and observational studies. In addition, it provides consulting services for new drug development, regulatory affairs, study start-up, medical writing and research, clinical operation, project management, data management, statistical analysis, pharmacovigilance (PV), epidemiological research, and quality assurance. LSK Global PS has conducted 1,277 clinical studies, including 144 global clinical studies and 110 IND studies, since its foundation (as of December 2020). It is the first Korean CRO to win a contract for an FIH (first-in-human) phase I study of an anticancer agent from a multinational pharmaceutical company, an achievement that was especially meaningful because LSK Global PS was competing against large global CROs to win this contract. Also, LSK Global PS has successfully completed a large-scale global phase III trial for an anticancer agent, which was conducted in 95 sites in 12 countries including the US, Europe, and Asia. In March 2017, LSK Global PS became the first Korean CRO which acquired the 'ISO (International Organization for Standardization) 9001:2015' certification for Quality Management Systems in the entire areas of services relevant with clinical trials. In December 2019, it became the first Korean CRO to acquire the 'ISO 37001' certification for Anti-Bribery Management Systems. LSK Global PS also became the first Korean CRO to establish a PV branch office in Europe in May 2019 and a DM (Data Management) branch office in Taiwan in February 2020.