Clinical Trial Design & Analysis
Clinical trials are the most expensive and time-consuming phase in drug development, with failure rates often exceeding 80% in Phase II and III. Our service tackles this by engineering trials using a combination of classical statistics, simulation techniques, and adaptive frameworks.
What we do
Adaptive trial design
Implement flexible trial methodologies that allow modifications based on interim data, enhancing efficiency and ethical standards (group sequential, sample size re-estimation, dose-finding).
Power & Sample Size Calculation
Determine optimal sample sizes to ensure statistically significant results without over-recruitment.
Endpoint Optimisation
Identify and refine primary and secondary endpoints to align with regulatory expectations and clinical relevance.
Interim Analysis Planning
Schedule and conduct interim analyses to make informed decisions on trial continuation or modification.
Bayesian Framework Integration
Incorporate prior knowledge and real-time data to update probabilities and improve decision-making processes.
Regulatory alignment
Our methodologies align with FDA's guidance on adaptive design (2019) and EMA's CHMP/EWP/2459/02.
Business Value
Designing smarter trials cuts cost, speeds up go/no-go decisions, reduces patient exposure, and increases the likelihood of success - all while maintaining regulatory confidence.