Biostatistics Services
Study Design & Protocol Support
- Statistical Input into Clinical Protocol Development
- Sample Size Estimation & Justification
- Study Design Consulting
- Randomization Strategy and Schedule Generation
- Evaluation of Raw Data Feasibility
- Statistical Input on Protocol Deviations
Randomization & Sample Size Services
- Randomization Methodology Design
- Schedule Generation
- Sample Size Re-estimation (Adaptive Designs)
Analysis Planning & Documentation
- SAP and Mock Shells Development & Review
- SAR Preparation
- Review and finalization of:
- CSR, TLFs and Data Monitoring Outputs
Advanced Statistical Analysis
- Exploratory Data Analysis and Visualization
- Statistical Modeling & Simulations
- PK/PD Modeling & Interpretation
- Interim Analyses with pre-defined stopping criteria
- Analysis for Publications & Regulatory Submissions