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 for Innovative Trial Design & Monitoring
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.
Joe Shih, PhD., Sr. Advisor for Innovative Trial Design & Monitoring
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.
Jules T. Mitchel, PhD., Sr. Advisor for Regulatory and Technology
Dr. Jules T. Mitchel is President and CEO of THI Pharma Services Inc., a consultancy dedicated to all aspects of Drug and Device Development, including Strategic Planning, Regulatory Affairs, and Clinical Research. During his 30 years in the pharmaceutical industry, including 4 years at Pfizer and as president of Target Health Inc., a full-service CRO based in New York City, Dr. Mitchel’s achievements include multiple Orphan Drug Designations; the marketing approval of drugs to treat Gaucher disease, head lice, emergency contraception, etc.; a device to prevent hair loss in women undergoing breast cancer chemotherapy, multiple IND and IDE submissions; participation in FDA meetings and management of multicenter clinical trial programs. Dr. Mitchel also sat on the Executive Committee of the Clinical Trials Transformation Initiative, a public/private partnership with Duke and FDA. At Target Health Inc., Dr. Mitchel also led the team in developing software tools to enable the “Paperless Clinical Trial,” a transformational process within clinical research that allows for real-time data entry through traditional EDC systems. Dr. Mitchel has a Ph.D. from NYU and an MBA from Pace University and is an Adjunct Professor at Rutgers University in the Department of Pharmacology & Toxicology.
Randall Hein, Sr. Advisor of Business Development and Strategy
Randall Hein is Founder & CEO of Heinsight LLC (08/2020-Present), where he provides advisory and consulting services to the investment community and early-mid market life science companies. Previously, he was Chief Development Officer and President of Advarra Consulting at Advarra, which provides institutional review board (IRB), institutional biosafety committee (IBC), research technology solutions and global regulatory compliance consulting services. Here, Randall was responsible for leading M&A and corporate integrations as well as strategic and organizational development. He was also responsible for the Advarra global consulting services organization providing GXP, QA, regulatory, compliance and human research protections services. Prior to Advarra, Randall was Senior Vice President, Clinical Research Services at PRA where he oversaw research operations including clinical, scientific, medical, and data services. Randall also previously held senior operational roles at MDS Pharma Services and Davita Clinical Research. Randall has significant expertise in clinical research development, clinical research technology, patient recruitment and engagement and emerging research trends.
Thomas Thevenet, PhD., Sr. Consultant for EU Regulatory Affairs and BD
Thomas Thevenet is a clinical pharmacist with more than 15 years of experience in clinical development in immunology, oncology, vaccines and radiopharmaceuticals.
He is trained and knowledgeable in clinical study methodology and GXPs, as well as in data management, biostatistics and clinical regulatory affairs.
After working for the Hospices Civils de Lyon Hospital in France, and the French National Institute of Health, he worked as a clinical development manager for several companies including Sanofi and Novartis.
From 2014 to 2018, he was the Clinical Development and Biometrics Director at Advanced Accelerator Applications, a Novartis company where after registering 18F-choline and 6-fluoro-18F-L-DOPA, he successfully registered 68Ga-oxodotreotide (NetSpot) and 68Ga-edotreotide (Somakit-TOC) as well as 177Lu-oxodotreotide (Lutathera) in the US and in the EU. He also initiated the early clinical development of 177Lu/68Ga-PSMA-R2 as well as 177Lu/68Ga-NeoB for AAA.
After AAA was acquired by Novartis, Thomas established himself as a senior consultant and advisor for the biotech pharmaceutical industry. Among other advisor and investor roles for medium and small biotech companies, he is operating as a freelance external Clinical Development Leader for ITM, a radiopharmaceutical company headquartered in Munich, Germany where he oversees the clinical development of a broad pipeline covering diagnostic and therapeutic drugs in neuroendocrine tumors, as well as prostate, gynecological and neurology oncology indications.
Thomas holds a PhD in Pharmacy from the French University of Lyon and a Special Degree (fellowship program degree) in Industrial and Biomedical Pharmacy from the same university.