ESTERN Medical is current with the latest statistical techniques in the literature as well as those accepted by the US-FDA, EMEA and other regulatory agencies.
Our Biostatisticians possess the critical thinking to assist Sponsors throughout the filing process.
ESTERN Medical extensive experience allows us to develop a statistically rigorous and customized plan for each project. Our plans reflect all relevant agency approvals and FDA/ICH guidance documents, as well as an understanding of pertinent medical and clinical issues.
ESTERN Medical execution of the data analysis plan produces report ready summary tables, data listings and figures for interpretation and inclusion in the study report or submission. A thorough verification and senior review process substantiates the accuracy and completeness of all statistical analyses.
Biostatistical Services include:
- Study Design
- Analysis Planning
- Data Monitoring Committee (DMC) – Statistical Support
- Adaptive Design Simulation & Statistical Modeling
- Randomization Schedule Preparation
- Statistical Programming, Validation and Reports