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Statistical Consulting Services

Insightful Statistical Consulting to Maximize Trial Success

Premier Consulting uniquely offers critical Statistical Consulting Services early in clinical trial program development. Bringing statistical expertise in constructing optimal trial designs for individual studies and study programs, we provide expert technical guidance on key statistical considerations required to ensure that trial objectives, endpoints and analytic approach adequately align with the sponsor’s regulatory strategy and commercial objectives. Our statistical consulting experience spans over early to late-stage human clinical trial programs across a wide range of therapeutic areas, including rare diseases and cell & gene therapies, as well as device development programs and natural history studies.

Our experienced statistical consultants bring a breadth of technical expertise in innovative trial designs and analysis methodologies, along with proven experience in representing sponsors at pivotal regulatory agency meetings. Backed by decades of experience in the industry, our consultants develop solutions from a perspective that links advances in statistical design and analytic methods with current trends in regulatory acceptance of recent innovative approaches, such as model-informed drug development.

With Premier’s Statistical Consulting offering, it is our mission to identify and implement important statistical considerations relevant to a sponsor’s intended trial and to develop optimal design strategies and analytic solutions that strengthen the scientific robustness of the trial and maximize the chance of trial success.

Our statistical consultants offer a wide range of services in support of sponsor trials, including but not limited to:

  • Consultation and development of statistical design approaches for the study synopsis or protocol, with experience in various types of trial designs, such as:
    • Adaptive dose-finding designs.
    • Seamless Phase I/II or II/III adaptive designs.
    • Model-based adaptive dose escalation designs.
    • Basket/Umbrella trial designs.
    • Multiple endpoint designs with approaches for handling multiplicity to optimize label language.
    • Diagnostic accuracy trial designs for device products.
  • Innovative approaches using modeling and simulation for in-silico trial designs to generate model-informed synthetic control arms.
  • Provide sponsor with statistical representation in regulatory interactions, e.g. pre-IND or Type C meetings.
  • Provide comprehensive clinical development planning involving protocol development with sample size calculation.
  • Statistical consulting on non-interventional studies, e.g. retrospective/prospective natural history or real-world data (RWD) studies.
  • Consulting on interim analysis strategies and interactions with data safety monitoring boards (DSMB).

Meet Our Experts

Shari Medendorp, MPH

Executive Vice President