Accurate data analysis is fundamental for a study’s success, and a well-designed and executed statistical analysis plan is essential to the thorough analysis and accurate interpretation of study data.
To those ends, the Aptiv Solutions biostatistics team provides cutting-edge statistical designs, implemented and overseen by leading experts in the field. Our biostatisticians provide insight into trial design, develop complex statistical analysis plans, assist Sponsors throughout the regulatory filing process and are experienced in all the major therapeutic areas. And our staff always stays current with the latest statistical techniques accepted by the FDA, EMA and other regulatory agencies.
- Study design
- Sample size calculation
- Statistical analysis & report writing
- Agency interaction & defense
- Interim analysis planning
- Data Monitoring Committee (DMC) statistical support
- Adaptive design simulation & statistical modeling