Diagnostic & Medical Device Clinical Trials
Statistical Consulting for Medical Device Companies
Clinical Trial Design, Execution, and FDA/CE Mark submissions for 510K, Premarket Approval (PMA), and Emergency Use Authorization
Diagnostic & Medical Device Clinical Trials
Statistics & Biometry Services
Sample size and Statistical Power Calculations
Writing of the Protocol Statistical Section
Case Report Forms Design
Randomization Plan and Programming
Writing of the Statistical Analysis Plans (SAP)
Design of Clinical Study Report (CSR) Tables, Listings and Figures (TLF)
Creation of SAS intermediate and Analysis datasets (CDISC Format)
Troubleshooting instrument and/or assay Issues/Problems
Statistical Presentations, Reports and Updates to Clinical and Project Teams
Clinical Study Report Writing and further TLF development
SAS Programming Services
Table & Listing Programming
Graphics & Plots
Quality Control (QC) Validation (Formal/Informal)
“Statistics is the grammar of science”
Karl Pearson