Medical Device

• Project Management
• Study Design / Protocol Development (Analytical and Clinical)
• Clinical Trial Oversight & Statistical Consultation
• Complex modeling (Simulations, Modeling)
• Analytical (Reproducibility, Stability) Analyses
• Clinical (Sensitivity, Specificity, PPV, NPV, Concordance) Analysis
• CRF Development (Paper or eCRF)
• Data Management / Data Import, Integration, Standardization
• Quality Assurance Audits