Biostatistics

Biostatistics are an important component of many preclinical studies and are at the heart of every clinical study, driving study design, study conduct, data collection, data analysis, and reporting. Our Biostatisticians are dedicated to meeting your timelines and supporting you throughout the entire development cycle, with quality controls being applied at all stages of the project to ensure high quality results. In parallel, our Data Managers and Medical Writers ensure that the correct data is captured, and avoid the collection of extraneous data. Biostatisticians are available on a per-project or full-time equivalent (FTE) basis, according to your needs.

Biostatistics Services

• Study design and endpoint development guidance 
• CRF review 
• Statistical consulting 
• Sample size estimations and randomizations schemes 
• Statistical analysis plan with mock tables, figures and listings (TFLs) 
• Data review sessions 
• SAS^® programming and validation of the results
• Statistical analyses and appendices (TLFs) for clinical study reports
• Derived analysis data sets
• CDISC-compliant data sets - compliant 
• FDA submission-ready package 
• Support study design via power calculations