Biostatistics and programming is a team of experts who are part of every clinical study, contributing from study design through compilation of a CDISC compliant report.

Biostatistics services include:

Input into study design and sample size calculations
Consultation during protocol development
Generation of randomization schemes
Assist in preparation of Statistical Analysis Plans (SAPs)
Biostatistical analyses, including PK, PD, and efficacy data
SAS Programming of Tables, Listings and Figures (TLFs)
Quality Control of TLFs
Input into the Clinical Study Report (CSR) for regulatory submissions to FDA, EMA and TPD
Preparation of CDISC data sets (SDTM and ADaM)

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