Study Design

At the heart of every study is a trial's design, which must be tailored to achieve company objectives. Such objectives may include:

• Proof of concept
• Regulatory submissions
• Post-marketing and vigilance
• Demonstrating superiority, non-inferiority or bio-equivalence
• Validation
• Scientific publication

TechnoSTAT will develop for your company the most efficient design to achieve study 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
• Interim analysis (superiority, futility, classic adaptive and Bayesian design, etc)
• Adaptive elements (classical, group-sequential, Bayesian, etc.)