Tai Xie, PhD
Chief Executive Officer

Dr. Tai Xie is the founder and CEO of CIMS Global and has been leading the company in its goal of reshaping the future of clinical trials since it was founded in 2011. He was previously the founder and CEO of Brightech International, which was acquired by Everest Clinical Research in 2022. Dr. Xie is an expert in his field with over 30 years of experience in clinical trial design, data collection and management, statistical analysis, and reporting.

Dr. Xie leverages his extensive experience and deep insight of clinical trials to lead his team to develop innovative and cutting-edge e-clinical solutions for solving most challenging problems in clinical trials and healthcare, including Dynamic Data Monitoring (DDM) for clinical trials, Source Data Automation Process (DSAP) and Universal Health Exchange (UHX). Dr. Xie also has a Ph.D. in Applied Math and Statistics from the University of Arizona. He is an avid researcher and has published several papers in distinguished journals such as Statistics in Medicine and Statistics in Biopharmaceutical Research on various topics including innovative trial design, dynamic data monitoring, 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.

Darian Madsen
Sr. Director, Business Development & Marketing

Darian Madsen leads CIMS’ go-to-market and business development efforts. An industry veteran of nearly 13 years, Darian has developed a foundational base of knowledge through his tenure at both Oracle and Medidata. He understands the overarching, yet individual needs of both sponsors and CROs, having worked with a variety of clients, from small biotech companies to major top pharma sponsors. Darian’s team specializes in effectively communicating the benefits of the CIMS product line to the industry, while developing internal processes and operations that help make our organization business friendly. Customer satisfaction, support, and growing the business to spearhead product innovation and development are his top priorities.

Randall Hein
Sr. Advisor of Business Development

Randall Hein is the Founder & Managing Partner of Heinsight LLC, which provides advisory and consulting services to the investment community and early-mid market life science companies.  Previously, Randall served as Chief Development Officer and President of Regulatory & Compliance Services for four years at Advarra, which provides institutional review board (IRB), institutional biosafety committee (IBC), research technology solutions and global regulatory and compliance consulting services.  Randall also served as Senior Vice President, Clinical Research Services at PRA for over six years and oversaw research operations including clinical, scientific, medical, and data services.  Randall has significant expertise in clinical research development, Phase I-IV clinical trials, clinical research technology, patient recruitment and engagement, and emerging research trends.

Lei Xie, MD, PhD
Vice President of Corporate Affairs
Lei is a highly experienced professional with a proven ability to drive success in the pharmaceutical and CRO industries. With a career spanning over 27 years that includes 9 years dedicated to clinical research and 19 years focused on protein therapeutic development, Lei has acquired a diverse pharmaceutical research and development background and remarkable leadership skills.

Lei joined CIMS Global in 2023 as the Vice President of Corporate Affairs and collaborates with other CIMS senior executives to drive company growth and success by developing and implementing strategic plans aligned with the company’s goals. 

Prior to CIMS, Lei served as the Senior Director of Safety Monitoring and Clinical Operations at Brightech International for nine years. Lei has established herself as a leader in Immunology and CMC with 19 years devoted to drug development at Schering-Plough and Bristol Myers Squibb. Her expertise spans the entire spectrum, from early-phase projects through to late-phase initiatives, supporting clinical studies, IND, and BLA filings.

Lei holds a Ph.D. in Immunology from the University of Arizona and a Doctor of Medicine from Sichuan University Medical School, China. She also has three years of clinical practice at the Sichuan University Medical School Cancer Center.