Stat4ward LLC provides statistical consulting services to pharmaceutical companies, medical device companies, diagnostic companies, as well as other fields that use general statistics. We have a team of well trained statisticians, together we have many years of real life experiences in pharmaceutical and IVD/LDT industries. Our focus is not only on data analysis, we provide significant inputs on study design, statistical analysis plan, data analysis and practical interpretation of the analysis results, critical decision making, submission, interaction with regulatory agencies, and publications. In particular, we provide statistical consulting services for

CDx development. We’ve supported multiple PMA submissions for CDx, and multiple 510k/De Novo submissions for IVD products. We also supported many LDT developments and submissions to Medicare
Clinical Trials
Biomarker Assay validation & Algorithm Development
Bioassay Validation (e.g. immunogenicity, diagnostics, clinical biomarkers)
Non-Clinical Studies (Preclinical, CMC)
Bioinformatics
Statistical Process Control (SPC)
General statistics (e.g., data mining, prediction modeling, pattern recognition)