Biostats delivered from study planning through to SDTM aDam datasets.
Supporting our clients means understanding their studies and the distinct statistical issues and needs they have in their therapeutic area.
Our biostatistics team is committed to delivering the quality and deliverables that you expect from Axiom. To accomplish this goal, we are focused on providing experience and a deep understanding of the latest statistical methods, with a focus on regulatory requirements.
We provide consultation, advice and services in the following areas:
- Protocol Development
- Sample Size Calculations
- Representation at Regulatory Agency Meetings
- Randomization Schedule
- Randomization List
- Statistical Analysis Plan (SAP) Development
- SAS Programming and Independent Validation of Tables, Listings, and Figures
- Interim Analysis Planning
- Topline Analysis Package
- Final Analysis Package
- DMC Statistics Services
- Integrated Summaries of Safety and Efficacy
- Statistical Reports
- Statistical Review of Clinical Study Reports
- Submission-Ready Services