Designing a first-in-human study is challenging. Designing one for a novel reproductive therapy with limited prior data and significant biological variability is even more complex.
In this case study, discover how Phastar partnered with an innovative biotechnology company developing a groundbreaking therapeutic aimed at improving IVF success rates through the reduction of chromosomal errors in oocytes.
Using advanced simulation methodologies and close scientific collaboration, Phastar helped transform uncertainty into a robust, statistically validated study design capable of delivering meaningful proof-of-concept evidence.
Download the case study to learn how:
- Simulation-based approaches informed sample size determination
- Multiple biological and treatment-effect scenarios were evaluated
- Critical assumptions were refined through scientific collaboration
- Key uncertainties were systematically explored and mitigated
- Primary endpoints were optimized to strengthen evidentiary value
- Statistical outputs were aligned with future development decisions
