EXPERT BIOSTATISTICS SERVICES
For over 10 years NoyMed biostatisticians provide high-quality services in all phases of clinical trials across the wide range of therapeutic areas.
Biostatistics services
- Sample size calculation and justification
- Protocol development and review (Statistical analysis section)
- Randomization schedule development
- CRF development and review
- Statistical analysis plan (SAP) preparation
- Mock Tables, Figures and Listings (TFLs shells) development
- Statistical analysis and report preparation
- Review and finalization of the datasets package for regulatory submission (SDTM, ADaM)
- Reviewers guidelines (SDRG and ADRG) development
- Result interpretation and assistance in the Clinical Study Report (CSR) development