Trial Design and Protocol Development

Good trial design is a key factor in moving investigational products and devices through the clinical trials process effectively and efficiently. Critical to the design of a trial is having scientifically and ethically sound protocols that can be practically implemented in the field.

Biostatistical Input

Westat staff can support all functions for designing effective clinical trials and developing sound protocols. Our biostatisticians are experienced in preparing statistical plans appropriate to the study phase and objectives, including sample size and power determinations. We also have the expertise in defining appropriate primary and secondary outcome measures and the statistical tests to use for data analysis.

Regulatory Affairs Input

Our Regulatory Affairs staff are industry trained and experienced in the regulations and guidelines applicable to clinical trials regulated by the Food and Drug Administration (FDA).

Westat's Regulatory Affairs staff help ensure study protocols are designed in compliance with applicable regulations and guidance for the protection of human subjects, as well as the reporting of serious adverse events that may affect the progress of the study. In addition, Westat's Regulatory Affairs staff reviews each protocol for compliance and quality control.

With an interdisciplinary team approach, Westat is flexible and responsive in meeting client needs.

Services

  • Protocol development
  • Planning and execution of non-inferiority/bioequivalence trials
  • Drug interaction modeling for parametric and nonparametric analysis
  • Sample size estimation
  • Interim analyses/statistical stopping rules
  • Randomization services
  • Analysis of PK/PD data