Biostatistics is central to clinical development strategy, trial design, regulatory approval, and evidence generation. Clinovalife provides scientifically rigorous, regulator-aligned biostatistical expertise to ensure trials are methodologically sound, analytically robust, and submission-ready across all phases of clinical development (Phase I–IV).
We integrate statistical thinking from protocol design through regulatory submission, ensuring compliance with ICH guidelines, FDA, EMA, PMDA and global health authority expectations.
Trial Design & Statistical Strategy
Study Design Consulting
- Superiority, non-inferiority, and equivalence designs
- Parallel, crossover, factorial, and adaptive designs
- Bayesian and innovative trial methodologies
- Endpoint selection strategy
Sample Size & Power Calculations
- Optimal sample size determination
- Power analysis for primary and secondary endpoints
- Event-driven study modeling
- Sensitivity analysis scenarios
Randomization & Blinding
- Randomization schedule generation
- Stratified and block randomization
- Interactive response technology (IRT) integration
- Blinding strategy consultation
Statistical Analysis Planning
Statistical Analysis Plan (SAP) Development
- Comprehensive statistical methodology documentation
- Missing data handling strategies
- Multiplicity adjustment strategy
- Interim analysis planning
- Subgroup analysis framework
Analysis of Population Definitions
- Intent-to-Treat (ITT) population
- Modified ITT (mITT) population
- Per-Protocol population
- Safety population definitions
- PK/PD analysis population definitions
Data Handling & Derivations
- Derived variable definitions
- Protocol deviation handling
- Covariate adjustment strategies
Interim & Final Statistical Analyses
Interim Analysis
- Data Monitoring Committee (DMC/DSMB) support
- Futility and efficacy assessments
- Adaptive design execution
- Unblinded statistical analysis when applicable
Final Analysis
- Primary and secondary endpoint analysis
- Sensitivity analyses
- Time-to-event (survival) analysis
- Longitudinal data modeling
- Comprehensive safety data evaluation
Integrated Analyses & Submission Support
Integrated Summary of Safety (ISS)
- Cross-study safety pooling
- Exposure-response analysis
- Signal evaluation
Integrated Summary of Efficacy (ISE)
- Cross-study efficacy evaluation
- Meta-analysis techniques
- Subgroup consistency assessment
Regulatory Interaction Support
- Statistical briefing documents
- Health authority meeting preparation
- Regulatory query response support
- Advisory committee statistical support
Advanced & Specialized Statistical Services
- PK/PD modeling collaboration
- Mixed-effects modeling
- Real-world evidence statistical evaluation
- Predictive modeling
- Risk-based central statistical monitoring
- Key Risk Indicator (KRI) statistical analysis
- Health Economics & Outcomes Research (HEOR) support
Quality, Compliance & Governance
- SOP-driven statistical workflows
- Independent quality control of statistical outputs
- Traceability between SAP and deliverables
- Audit and inspection readiness
- 21 CFR Part 11 compliant systems
Our Biostatistics Value Proposition
- Early-phase statistical strategy integration
- Regulatory-aligned methodology development
- Integrated safety and efficacy analysis expertise
- Advanced modeling capabilities
- Inspection-ready statistical documentation
- Seamless collaboration with CDM and programming teams