Biostatistics is the application of statistical methods to the design, analysis, and interpretation of data from clinical trials, observational studies, and other research studies involving human subjects. Biostatistics is used to help ensure the safety and efficacy of drugs, as well as to support the development of new drugs and therapies.
List of our Services:
- Statistical input into study design and protocol development
- Randomization
- Sample size calculation
- Develop and review SAP and mock shells
- PK/PD analysis
- Write and review statistical sections of CSR
- Post-submission regulatory query resolution
