Biostatistical Analysis
This service provides expert statistical and methodological consultancy for paediatric clinical studies, covering all phases from design to final reporting. Activities include sample size calculation, randomisation list generation, and preparation of Statistical Analysis Plans (SAPs); conduct of interim and final analyses with validated methods; and generation of summary tables, listings, and figures suitable for regulatory submissions. It also ensures compliance with data standards through CDISC formatting (SDTM/ADaM), including updating of historic datasets, and delivers ICH E3-compliant Statistical Analysis Reports (CSR-ready) to support regulatory approval and publications.
