A Passion for Improving the Clinical Trial Process
AI + Statistical Modeling + eClinical is creating a new paradigm
A Breakthrough in Clinical Trial Management
Driven by a passion to optimize the clinical trial process, Dr. Xie sees the convergence of EDC and IWRS, statistical modeling and machine learning that can reshape the future of clinical trials.
Dr. Xie is the founder and CEO of two companies: CIMS Global and Brightech International. He has over 24 years of clinical trial experience in pharmaceutical and CRO business. Dr. Xie is an expert in clinical trial design, clinical data management, eClinical Solutions and statistical analysis. He leads a team of over 100 statisticians, data analysts and software developers to provide DTD, DTM and eClinical Solutions to the pharmaceutical industry.
Tai Xie, PhD., CEO
Dr. Tai Xie is the founder and CEO of CIMS Global. Dr. Xie has over 20 years of experience in clinical trial design, data collection and management, statistical analysis and reporting. In 2009, Dr. Xie acquired Shanghai Magnsoft Software Development Ltd., which developed the first Clinical EDC system in China. Since then, he serves as CEO and leads a team of developers to further enhance the EDC system into an Integrated Clinical Information Management Suite (CIMS). Dr. Xie is also the president and CEO of Brightech International, a data focused CRO providing clinical data management, statistics and SAS programming for pharmaceutical and biotech companies. Brightech has over 70 employees in US and over 30 in China. Prior to Brightech and CIMS business, he held an Associate Director position of Biostatistics and Data Management at ImClone (now a part of Eli Lilly, 2 years), Assistant Director at Wyeth (acquired by Pfizer, 5 years) and Sr. Statistician at JNJ (2 years). He served three years as CEO of Biopharm Solutions, a biotech company focused on innovative drug delivery technologies. Dr. Xie is also an Adjunct Assistant Professor of Biostatistics Department, School of Public Health at the Rutger University. Dr. Xie obtained his doctoral degree in Applied Math and Statistics at University of Arizona in 1993. He has extensive experience in clinical trial design and statistical analysis and reporting, clinical data management, EDC, eClinical and eHealth. In recent years, Dr. Xie has been actively interacting with the regulatory authority and drug industry in China. He was invited several times by China’s CFDA to participate in authoring the guidance on EDC and by influential professional organizations (such as China Heart Congress, CHC) to deliver courses and speeches on a variety of topics. Dr. Xie is also an active researcher with a number of research papers published in distinguished journals on various topics including cancer prevention, adaptive design, survival analysis, personalized medicines and more.
Kuang-Kuo Gordon Lan, PhD., Sr. Advisor
Dr. Lan received his PhD in Mathematical Statistics (1974) from Columbia University. After his Ph.D., Dr. Lan worked at NIH as Mathematical Statistician (1980-1989), Professor of Statistics and Biostatistics at George Washington University (1989-1995), Senior Technical Advisor/Distinguished Scientist at Pfizer (1995-2002), Research Fellow at Sanofi-Aventis (2002-2005) and Senior Scientific Director at Johnson & Johnson (from 2005 until retired in January 2019). He is serving as our Sr. Statistical Advisor. Dr. Lan has published over 70 research papers on statistical methods in medical research and has given over 230 invited talks at universities and professional meetings worldwide. His most notable contribution is the development, with Dr. David DeMets, of the alpha spending approach to the design and interim analysis of clinical trials. He is also a co-author (with Drs. Mike Proschan and Janet Wittes) of the guiding book titled “Statistical Monitoring of Clinical Trials: A Unified Approach”, which is widely used by industry and academia as a textbook in clinical trial design. Gordon was elected Fellow of the American Statistical Association in 1992, and Fellow of the Society of Clinical Trials in 2009.
Ping Gao, PhD., Sr. Director and DDM/DTD Development Team Leader
Ping Gao received his Ph.D. at the Department of Mathematics, University of Washington, in the field of stochastic analysis. He held a post-doctoral fellowship in Biostatistics at the University of Rochester, where he did research in survival analysis and counting processes. He had worked at the FDA, pharmaceutical companies and CROs for over 20 years. Ping’s experience and knowledge of clinical trial designs includes non-inferiority, phase 2/3 seamless combination, population enrichment, multiple dose selection, adaptive designs and dynamic data monitoring with a number of papers published in peer reviewed journals and implemented in several commercial statistical software. Ping has designed large cardiovascular trials that enrolled more than 10,000 patients, as well as phase 3 trials for rare diseases that enrolls very small sample sizes. Ping’s working experience includes therapeutic areas such as cardiology, anti-infective, oncology, hemostasis, and rare diseases. Ping’s research interest includes non-inferiority and adaptive designs.
Joe Shih, PhD., Sr. Advisor
Dr. Joe Shih, Professor Emeritus of Biostatistics (July 1, 2019), and former Chair of Biostatistics Department (1999-2017), School of Public Health, and Director of Biometrics Division of the Cancer Institute of New Jersey (1999-2019), Rutgers University – the State University of New Jersey. Prior to joining academia, he spent formative years at Merck Research Laboratories. He served in the US FDA’s Advisory Board for reviewing new drug applications. He is a distinguished and influential statistician and scholar in industry and academia. He has collaborated extensively with physicians in various therapeutic areas and published over 150 papers in statistical methodology and medical research. His book “Statistical Design and Analysis of Clinical Trials” is a top-chosen graduate level textbook for many universities. His expertise includes adaptive designs and missing data issues in clinical trials, and evaluation of therapeutic interventions.
Thomas Thevenet, PhD., Sr. Consultant of EU Regulatory Affairs and Marketing
Dr. Thomas Thevenet, Sr. Consultant of EU Regulatory Affairs and Marketing. Thomas is a clinician with more than 14 years of experience in clinical development. He is trained and knowledgeable in clinical study methodology and GXPs, data management, biostatistics and regulatory affairs. After his residency at the Hospices Civils de Lyon, France, he worked for several medical device and pharmaceutical companies including Sanofi and Novartis. Recently, he was successively Clinical Development Manager and Biometrics Director at Advanced Accelerator Applications, a Novartis company, where he led the clinical development and the marketing authorization (EMA and FDA) of the first in class theragnostic radiopharmaceutical pair (Lutathera and Somakit TOC/NETSpot) which is broadly approved for treating neuroendocrine tumors. Thomas holds a PhD in Pharmacy from the French University of Lyon and a Special Degree in Industrial and Biomedical Pharmacy from the same university. He now works as an independent consultant in clinical development for several companies.