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.

The number of approved clinical trials in Korea rose by 30, or 4.8 percent, in 2017 from a year earlier, according to the Korea National Enterprise for Clinical Trials (KoNECT)’s analysis of trial plans approved by the Ministry of Food and Drug Safety. The increase was owing to a 26.3 percent rise in multinational drugmakers’ clinical trial plans and a 10.5 percent growth in researcher-led studies.

With more global clinical trials taking place in Korea, LSK Global Pharma Services, a local contract research organization (CRO), is drawing attention with its strength in full-range service for clinical studies.

In the past, large-sized multinational CROs used to lead global studies in Korea. However, Korean CROs are increasingly participating in the clinical research market.

Established in 2000, LSK Global PS has conducted more than 982 clinical trials including 115 global studies until 2017. In 2010, the company was the first Korean CRO to sign a deal for the First-in-Human (FIH) phase-1 study for an anticancer agent sponsored by a U.S.-based multinational pharmaceutical firm.

LSK Global PS is currently offering service for global, multi-center clinical trials at 95 sites in 12 countries. To boost global studies, the company has built partnerships with 21 institutions around the world, operating an international CRO network.

LSK Global PS says it offers “full service” for clinical research in all stages. The Korean CRO’s integrated service includes product development, regulatory affairs, study start-up, clinical operation/monitoring, global project management, data management, biostatistics analysis, epidemiology research, pharmacovigilance, and quality assurance.

In Korea, the company’ service encompasses all of the phases in clinical trials. The CRO has strengths in data management and biostatistics analysis, it said.

In March 2017, LSK Global PS obtained “ISO (International Organization for Standardization) 9001: 2015,” quality management system certification that meets international standards in the development and operation of a full-range service for clinical trials and clinical training programs. As a result, the company became the first Korean CRO to receive ISO’s service quality certification for all clinical trial services.

LSK Global PS said it has a competitive edge in its clinical trial management system as well. The CRO conducts a study using the Clinical Trial Management System (CTMS), Pharmacovigilance: Aris Global Safety Database, and Central Imaging Service/Keosys.

LSK Global PS has the largest number of data managers and statistical analysts in Korea, the company said. In 2012, it became the first Korean CRO to set up a Pharmacovigilance (PV) team to autonomously support the post-marketing surveillance service for drug safety.

In addition to safety information management, the PV team provides all necessary services for drug monitoring such as building safety database, setting up a risk management plan (RMP) for each drug, and providing the Periodic Benefit-Risk Evaluation Report (PBRER).

As the only CRO in Korea, the company’s PV team has four PV experts qualified for European Medicines Agency (EMA)’s EudraVigilance ICRS (Individual Case Safety Report) electronic reporting. The four professionals also have completed getting training and evaluation of eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).

"Based on our accumulated experience, LSK Global PS provides clinical trial services that meet global standards. We help not only Korean but foreign pharmaceutical companies to conduct successful clinical trials in Korea,” said Lee Young-jack, CEO of LSK Global PS. "We will do our best to help Korean drugmakers enter the global market so that LSK Global PS can achieve its ultimate goal of enabling locally-developed new drugs to become international blockbusters.”

lhs@docdocdoc.co.kr

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