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We have fine group of people who dedicated to provide quality, accuracy, efficiency and trust to our clients.  Chae Yong Chang
President Chaeyong has worked on several NDA submissions during his over 10 years of Pharmaceutical experience. While he has worked on the Prilosec OTC conversion submission which includes pivotal studies, ISS, ISE, SNDA, IND, advisory committee preparation, eNDA submission. He has experience implementing CDISC SDTM using 3.1.1 and 3.1.2 and ADaM. He has worked at Proctor & Gamble, Forest Lab, Abbott Lab and Eisai. Before, he join the Pharma industry, he has worked at the Prevention Center (CDC funded research center) for five years. Kevin L. Ross, Ph.D, RAC
V. P. Dr. Ross has brought to us over 20 years of Regulatory experience for US FDA, European and Japanese authority. He has worked at Proctor & Gamble, Kendle and Eisai. He has directed the regulatory affairs department responsible for management of commercial and investigational drug products for gastrointestinal, anti-infective, cardiovascular, and endocrine categories, supporting global filing regions. Jerry K. Lee, M.D., Ph.D.
V. P. Dr. Lee has been working as a principal investigator for the GI study, Glumetza study, Suboxone study, COPD study. He is a Certified Physician Investigator (CPI), APPI. He has received his Ph.D in statistics at Ohio State University in 1987 and has received his M.D. at the Chicago Medical School . He has actively involved in both Statistical and Medical research throughout his career. C.K. Park, Ph.D.
V. P. Dr. Park has been working as a Associate Director of GSK prior to join us as V.P. of our company. He has been working in wide array of scientific and clinical areas including observational studies, meta-analysis, microarray analysis, proteomics, and QT correction methods using both statistics and data mining tools. Also, he has many years of experience doing the NDA submission at Covance, Inc. T.Y. Lee, M.S.
Director T.Y. Lee has over 20 years of experience at SAS and has worked on Phase III G.I. studies. He has been working on the financial sector studies through out his career and now has joined us for the clinical studies. He has received his MS of Economics from U. of N. Carolina and MS of Stat from N.C. State University. Kwanhey Jung, M.S..
Associate Director Kwanhey has over 17 years of experience in scientific data analysis and over 7 years of experience in Data Management and analysis in clinical trial. CDISC team
We have a group of team who have done several CDISC implementation services to our clients. We have SAS based program that will deliver needed CDSIC data set. We have developed a tool which will deliver define.xml using CDISC stylesheet. Our CDISC team has worked on Phase II & III study implementing SDTM in both 3.1.1 and 3.1.2. Also, has provided CDSIC compliance check for the Phase I, II & III studies. |