Biostatisticians with extensive regulatory experience

Our biostatisticians are inwolved from beginning to end, bringing extensive therapeutic area and regulatory experience to ensure endpoints, analyses, and data collection with reaulatory precedent. In last 6 years, we have provided consultant to more than 20 clients with FDA IND/NDA projects. 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 praduct approvals.

One team. One goal. When you choose to work with us, we become an extension of your development team, ready to share ourholistic expertise in study design, execution, and regulatory submissions Colaborative, agile, and committed, our statisticiansconsistently support your program from phase /2 through regulatory submission. COur continuity allows far concurrent Phase 3ond integrotion work, resulting in reduced timelines to market.

Quality analysis and reporting

Al of our biostatisticians have adwanced degrees, collectively average mare than 10 years of experience in biometrics, andremain current with industry standards,such as released lCH and FDA quidance documents. Starting with a wel-developedanalysis plan,Rho biostatisticians and programmers collaborate to deliver CDlSC compliant datasets, along with tables,istings, and figures, that align with your study objectives.

Flexible support models

Your pragram deserves a tailored approach. Whether you need full service ar stand-alone services, our biostatisticians are:ommitted to providing collaborative, flexible and innovative approaches to your rescue study ar 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
• Pharmocokinetic/Pharmacodynamic anatyses

• Integrated analyses (1S5/1SE)

Marketing application support
• CSR support
• Consultation