Study Design and Planning

At the heart of every study is a trial’s design, which must be tailored to achieve company objectives. TechnoSTAT will develop for your company the most efficient design to achieve these objectives. Where needed, we will provide you with pre-trial, continuous and/or post-trial support vis-à-vis regulatory agencies.

We shall assist your company in determining key aspects of study design, such as:

  • Number and types of arms
  • Sample size
  • Randomization design
  • Endpoints
  • Analysis populations
  • Interim analysis (superiority, futility, non-inferiority)
  • Adaptive elements (classical, group-sequential, Bayesian)

Once designed, TechnoSTAT will write and/or review the trial’s protocol in a manner consistent with study objectives and relevant regulatory guidelines. Working together with you, we make the efforts required to have the protocol be favorably received by ethics committees, investors, scientific journals and/or regulatory agencies.