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Consultant Team

The Innovative Trial Design Group

When it comes to thought leadership in data services, there are few companies that can match Brightech. For many of our clients, the most valuable work for our clients is our expert study design from our consultant team and company leadership. With an efficient study design, we can get you to submission with confidence that you have the most effective approach.

The services will be provided by our Innovative Trial Design Group composed of experts and KOLs from industry and academia, as well as an experienced statistical programming team Brightech knows the FDA regulation and the proper statistical approach, helping sponsors design the efficient studies, through regulatory to the final submission package.

Our expertise with innovative study design (group sequential, adaptive and dynamic adaptive design), sample size estimation in design stage and re-estimation in interim stage and interim analysis allows us to deliver the most efficient path from study design to database lock.

Dr. Gordon Lan

Dr. Gordon Lan, a pioneer in establishing the fundamental theory of Group Sequential Design.  He has 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.

Dr. Joe Shih

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.

Dr. Tai Xie

Dr. Tai Xie, founder and CEO of Brightech and CIMS Global.  Tai is an industry pioneer focused on reshaping the future of clinical trials through the convergence of EDC and IWRS, statistical modeling, machine learning and A.I.. He is leading a team to develop innovative tools for future clinical trials, including Dynamic Adaptive Design (DAD), Dynamic Data Monitoring (DDM), Clinical Information Platform (CIP) and seamless clinical data processing from data capture to SAS output. Dr. Xie has over 27 years of experience in trial design and conduct.

The ITDG services include, but are not limited to:

  • Innovative Trial Design
    1. Group Sequential Design
    2. Adaptive Sequential Design
    3. Dynamic Adaptive Design
    4. Phase II/III seamless design
    5. Adaptive Sequential Design with multiple comparisons
    6. Simulations for comparing different designs
  • Design and strategy for natural history studies in rare diseases
  • Design and data analysis of RWE studies
  • Statistical analysis strategies for missing data
  • Serving as Independent Statistician or DMC voting member
  • Serving as Mock-up FDA Advisory Committee member for NDA or BLA