Global Statistics Group, Inc.

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.  

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.

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 Univeristy.

Miyoung has worked Banking industry before she join the Pharmaceutical industry.  She has worked on Phase I ISS/ISE trials, Phase II & III Anti-Infectious drug, Phase II Epilepsy trials and Phase III GI studies.  

We have a gorup 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 developped 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.