Biostatistics for Medical Device Clinical Trials
Our Ph.D. and Master’s-level biostatisticians play a critical role in the application of statistical and research methodological principles for the design, execution and analysis of medical device clinical trials. They work closely with clients to ensure that clinical studies are conducted in accordance with regulatory requirements and client objectives.
Aptiv Solutions provides a variety of biostatistics support for all phases of pre-clinical studies and clinical trials, including:
- Pre-clinical and clinical program consultation
- Protocol design, development and statistical analysis plan development to ensure consistency with the final protocol
- Randomization schemes and sample size justification
- Generation of statistical summary tables, graphs and reports using SAS for regulatory submissions, presentations, and publications
- Interim and final statistical analysis and reporting