Biostatisticians with extensive regulatory experience
Our biostatisticians are involved from start to finish, bringing extensive therapeutic area and regulatory experience to ensure endpoints, analyses, and data collection align with regulatory precedent. In the last three years alone, we have represented more than 30 clients at FDA meetings. Whether you need a quick power calculation or an in-depth review, your request is in the hands of industry-leading biostatisticians with a proven track record of successful product approvals.
Faster to market
One team. One goal. When you partner with us, we become an extended part of your development team, ready to share our holistic expertise in study design, execution, and regulatory submissions. Collaborative, agile, and committed, our statisticians consistently support your program from Phase 1/2 through regulatory submission. Our continuity allows for concurrent Phase 3 and integration work, resulting in reduced timelines to market.
Quality analysis and reporting
All of our biostatisticians have advanced degrees, collectively average more than 10 years of experience in biometrics, and remain current with industry standards, such as released ICH and FDA guidance documents. Starting with a well-developed analysis plan, Rho biostatisticians and programmers collaborate to deliver CDISC compliant datasets, along with tables, listings, and figures, that align with your study objectives.
Flexible support models
Your program deserves a tailored approach. Whether you need full service or stand-alone services, our biostatisticians are committed to providing collaborative, flexible and innovative approaches to your rescue study or development program.
Our biostatistics services include:
- Study design
- Protocol development
- Estimand development
- Sample size calculations
- Randomization schedule and plan creation
- Statistical Analysis Plans (SAP)
- Statistical analyses
- Pharmacokinetic/Pharmacodynamic analyses
- Integrated analyses (ISS/ISE)
- 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.