Biostatistics
Averion’s genesis was in statistical consultation. Building upon this foundation, Averion continues to lead the industry today. Averion is current with the latest statistical techniques in the literature as well as those accepted by the FDA, EMEA and other regulatory agencies. Our senior Biostatisticians have served as independent reviewers of major studies in many therapeutic areas. They bring expertise and insights in designing trials and developing complex statistical analysis plans. Our Biostatisticians posses the critical thinking to assist Sponsors throughout the filing process. Our statistical programmers are current with the latest programming techniques and features of the SAS system, among other statistical software packages. Additionally, they are experienced with CDISC data standards, electronic submission standards and Averion's standards, to deliver high quality, dependable analyses.
Averion's extensive experience allows us to develop a statistically rigorous and customized plan for each project. Our plans reflects all relevant agency approvals and FDA/ICH guidance documents, as well as an understanding of pertinent medical and clinical issues. Averion's execution of the 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
- Interim Analysis Planning
- Data Monitoring Committee (DMC) Statistical Support
- Adaptive Design Simulation & Statistical Modeling
- Randomization Schedule Preparation
- Statistical Programming and Validation
- Statistical Reports
- Agency Representation