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Iris Statistical Computing is a specialized consulting firm serving small to mid-size biotech and pharmaceutical companies. The company focuses on ensuring quality and timely FDA data submission filings for New Drug Applications (NDAs) and Biologics License Applications (BLAs). Their expertise includes statistical analysis, CDISC data package evaluation, sample size estimation, multiple hypothesis testing, interim analyses, non-inferiority testing, and related regulatory writing. Founded by Lisa Brooks in 2007, the firm uses proprietary checklists and processes to evaluate submission readiness[1][3][7].
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