Biostatisticians with extensive regulatory experience
Our biostatisticians are involved from start to finish, bringing extensive therapeutic area expertise to ensure endpoints, analyses, and data collection align with regulatory precedent. Whether you need a quick power calculation or an in-depth review, our statisticians can support all requests.
Our senior statistical scientists enjoy close working relationships and frequent dialogues with the FDA, possess extensive regulatory experience, and have held governance roles within the Drug Information Association (DIA), American Statistical Association (ASA), and Society for Clinical Trials (SCT). We always work with the end in mind, informed by our extensive regulatory interactions.
Our statisticians provide the following services:
- Study design
- Protocol design
- Sample size calculations
- Statistical analyses
- Integrated analysis (ISS/ISE)
- End point analysis
- Marketing application support
- CSR support
Rho statisticians apply their expertise not just in routine efforts, but also never stop working to give sponsors the best chances at approval. Following a failed pivotal trial, we were able to put forth additional analyses in the supplemental marketing application that resulted in the sponsor getting their desired labeling.