a leading Contract Research Organization (CRO) in Korea and is making its endless effort to contribute to the expansion of Korean pharmaceutical industry into the global market
Since March 2000, when LSK Global PS kicked off its business, LSK Global PS has established its position as a one-stop, full-service CRO encompassing all of the major areas of clinical research, i.e. registration trials from phase I to III, investigator-sponsored clinical studies, post-registration studies such as phase IV studies, PMS studies, observational studies, etc., and consulting services for new drug development. December 2020, we have conducted about 1277 clinical studies so far, including about 715 registration trials and about 144 global clinical studies.
Through various global clinical trial opportunities, we developed partnerships with a number of local and overseas pharmaceutical companies as well as global CROs and we also equipped ourselves with abilities to provide total solutions for new drug development and clinical trials. In other words, we were able to leverage our expertise obtained through those opportunities to evolve from a CRO into a partner for new drug development.
In addition, we are in a position to address our clients’ higher-level requests with our effective communication process, risk management plan and problem-solving skills, making the process of planning and implementing clinical trials more smooth. In sum, improved cost effectiveness and reduced opportunity cost that we bring to our clients through our accumulated know-how and expertise and effective risk management are the basis for gaining client satisfaction and building business credibility.
Our stabilized system for clinical research management that we have established through our experiences gives us a capability of keeping up with global standards in planning study design and implementing clinical studies.
We noticed a recent trend that local clinical trials as well as multinational, multicenter studies call for increasingly large number of sites and, to keep pace with such trend, we introduced Medidata CTMS® Solutions first among CROs in Korea. Medidata CTMS® Solutions improved the operational effectiveness and decision-making process of the clinical studies.
At LSK Global PS, we have always pursued an advanced level of data management service so that we can provide specialized data. We offer a full-package solution to data management by using Target Health e*CRF, Medidata Rave, Oracle InForm and other internationally certified system solutions for Safety Management and Central Imaging Service, etc.
As evidenced by the audits on our system, performed by numerous global CROs and pharmaceutical companies, and the MFDS inspections, we excel in the quality of our services in clinical development and operations, which is highlighted by our winning of a contract for the First-in-Human (FIH) phase I study for an anticancer agent that is sponsored by a US multinational pharmaceutical company. By this achievement, we became the first CRO in Korea who won a contract for an FIH study from a multinational pharmaceutical company and this was more meaningful in that we competed against global, big CROs to win this contract.
Our expertise and know-how that we accumulated from these global clinical trial experiences helps us to gain client satisfaction and build business credibility and this expertise and know-how also paved the way for evolving ourselves from a CRO into a partner for new drug development. As our business grows, so does our effort to constantly contribute to the entry of locally developed pharmaceuticals to the global market.
Going forward, LSK Global PS will make every effort to play a pivotal role in developing clinical research industry in Korea and to be a successful partner for Korean pharmaceutical companies in their entry into global market.
Since its establishment in March 2000, we, at LSK Global PS, have tried hard to fulfill our mission – that is to contribute to the entry of Korean pharmaceutical companies to global market - and we have pursued highest quality in the services we provide. We have constantly made efforts to provide contract research services that meet global standards. To keep up the quality of clinical trials, we use the systems meeting global standards and conduct the clinical trials according to our SOP, which was developed to be in strict compliance with the ICH-GCP guidelines.
The competitiveness that we have is the quality of our clinical research service that fulfills the regulatory requirements of US and Europe. With this competitiveness, we moved forward to become the first CRO in Korea who successfully completed a global clinical trial for a new drug.
I started my clinical research career in 1977 when I worked with the US National Cancer Institute. I continued my career in the clinical research field and, just before I came back to Korea in 1999, I served as Chief of the Biostatistics Branch at the National Institutes of Health (NIH). In 1999, I established a CRO company with my vision to contribute to the development of Korean clinical research industry and I am still actively participating in different areas of the clinical research projects such as study design, data analysis, consultations, etc.
The past 23 years at NIH gave me opportunities to experience practically all of the different areas of clinical research, including study planning, study design, monitoring, site management, data management, data analysis, report preparation, result presentation, etc. Looking back, the basics of clinical research have not changed whether in Korea or in other countries although the services of CRO are now more diversified and specialized. We have tried to stick to the basics, i.e., data transparency and integrity, and have worked hard to bring out the best in data transparency and integrity. What we have strived for is none other than the highest quality.
We, at LSK Global PS, promise to forge ahead with our efforts to take the competitiveness of Korean clinical research industry to the global level and to contribute to the entry of Korean pharmaceutical industry into the global market.