Biostatistics is at the heart of every clinical research. With scientific roots and in-depth clinical and regulatory experience, our team understands the scientific issues, anticipating and overcoming potential challenges specific to your clinical trial. Therefore, Clinmark delivers optimal study designs with best practice randomization methods, as well as timely statistical analysis in order to produce clinical trial results that are scientifically accurate, validated, and reproducible.
Clinmark’s biostaticians provide the customers with support in all phases of drug or device development. We offer the following biostatistical services:
- Sample size calculation and consulting of statistical issues at the stage of study design and protocol development
- Statistical Analysis Plan (SAP) development with Mock TLF (Tables, Listings, Figures) generation)
- Statistical interim and final analyses
- Writing SAR (Statistical Analysis Report)
- CSR statistical review and generation of subject listings (CSR appendix)
- Archiving statistical documents
- Randomization
- CDISC ADaM / define-XML / Reviewer’s guide