Introducing the Innovative Trial Design Group (ITDG)

About the Innovative Trial Design Group (ITDG)

CIMS, the pioneer of dynamic trial design (DTD) and dynamic data monitoring (DDM), announced new services offered to the pharmaceutical and biotech industry. The new services include, but are not limited to, the following:

  • 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

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. Several key members are listed below.

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. 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, founder and CEO of Brightech and CIMS.  Tai is an industry pioneer focused on reshaping the future of clinical trials through the convergence of EDC and IWRS, statistical modeling and machine learning. Dr. Xie has over 20 years of experience in trial design and conduct.

 Dr. Ping Gao, with over 20 years of experience in FDA and industry. He has exceptional 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.

Contact us to learn more about this unique service at:

+1.844.491.7480 (toll free) or +1.908.340.7888

Email: support@cims-global.com

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