Accurate statistical analysis is a fundamental component of a successful clinical trial, and QST is committed to providing a comprehensive and accurate statistical analysis plan tailored to your study.
Our biostatisticians can help you design a successful trial, provide recommendations based on our statistical knowledge, create reports and help interpret your data to ensure timely and accurate results. QST staff will work closely with you to ensure that all studies are conducted to meet the requirements of all regulatory agencies.
- Statistical consulting and statistical summaries
- Study design for NDA, ANDA, PMA, and 510(k) programs
- Statistical Methods Design
- Sample size computations, power computations, and power analyses
- Generation of randomization code and submission of randomization lists
- Development of Statistical Analysis Plans
- Production programming and QC programming of statistical analyses (e.g., tables, figures, listings, patient profiles)
- Patient population determinations
- Production of submission-ready datasets following electronic NDA guidelines or CDISC guidelines (according to SDTM and ADaM format standards) including annotated CRF and define documentation
- Data transfers
- Design, development, and production of ISS/ISE integrated summaries of safety and efficacy (e.g., tables, figures, listings, integrated datasets)
- Data Safety Monitoring Board support
- Annual report support
- Clincialtrials.gov reporting support