Stat One, LLC provides statistical consulting services in support of pharmaceutical, biotechnology and medical device submissions. Our 30 plus years of experience include, protocol development and sample size calculation; statistical analysis planning, data analysis, production programming, study design, regulatory strategy, FDA representation, and DMC/DSMB activities.
We have knowledge in a broad range of therapeutic areas and have been involved in numerous studies that were cleared or approved in all areas of the FDA including PMAs, 510(k)s, NDAs, BLAs and INDs.
Statistical Services provided include:
- Assistance with Study Design and Statistical Methodology
- Protocol Review and Statistical Sections
- CRF Review and Design
- Statistical Analysis Plan (SAP)
- Sample Size Calculation
- Production Programming (Tables, Listings and Figures)
- FDA Representation
- Ad-hoc Statistical Analyses
- Publication Support