Led by our founder and CEO, PROMETRIKA’s statistical consultants provide sponsors with innovative and thoughtful strategies for clinical development planning, study designs and regulatory submissions.  With the ever increasing complexity of drug development methodologies, including the use of master protocols, adaptive designs, and natural history and real-world data, it is imperative for sponsors to collaborate with biostatisticians who have the depth of experience to help them develop well-suited trial designs and assist them through the regulatory submission process.  Over many years of collaboration, our senior statistical team has consulted on and executed hundreds of clinical trials in a multitude of therapeutic indications, and has completed over 20 successful NDA/BLA submissions.    

Working closely with medical, clinical, and other experts within a sponsor’s team, we gain an in-depth understanding of the goals and challenges specific to each clinical program.  By asking the pertinent questions and evaluating a variety of what-if scenarios, we assist sponsors in optimizing their study designs and regulatory strategies across all phases of clinical development.  Our subject matter experts use computer simulations to assess the statistical properties of complex trial designs, and participate with sponsors in FDA meetings to present proposed designs and analysis methodologies.  With a particular focus and commitment to advancing research in rare diseases, we offer statistical approaches designed to address the intricacies of these studies, including the use of adaptive designs and natural history data to increase disease understanding and maximize trial efficiency. 


  • Clinical Development Planning
  • Computer Simulations for Evaluating Trial Designs
  • Statistical Study Design
  • Complex Adaptive Trial Design and Analyses
  • Sample Size Estimation
  • Meta Analyses
  • Regulatory Interactions and Briefing Document Review
  • NDA Submission Strategies
  • Innovative Strategies for Rare Disease Studies
  • Participation on Data Monitoring Committees
  • Design and Analysis of Natural History Studies
  • Statistical Training for Non-statisticians
  • Surrogate Endpoints for Accelerated Approval
  • Support of Study-level Data Analytics
  • Design and Analysis of Studies with External Control Arms
  • Support for Abstracts, Posters, and Manuscripts