Biostatistics & Data Management Services for Clinical Trials
Powering Confident Decisions with Regulatory-Ready Analytics
At Globyz Clinical Solutions, we transform clinical data into actionable insights. Our biostatistics and data management experts ensure your trials are scientifically robust, compliant, and optimized for regulatory success—from protocol design to final submission.
Why Choose Globyz for Biostatistics?
Regulatory-Compliant Methodologies
Global standards alignment (ICH/FDA/EMA/PMDA)
Submission-ready statistical packages
Advanced Study Design & Analytics
Innovative trial designs
Complex data solutions for all study phases
Full-Service Trial Support
End-to-end statistical leadership
Therapeutic area expertise across indications
Efficient, Actionable Results
Optimized study timelines
Clear, decision-driving outputs
“Your data deserves more than analysis—it demands strategic intelligence.”
Comprehensive Biostatistics & Data Management Services
Protocol & Study Design
Smart Endpoint Selection – Align outcomes with regulatory & therapeutic goals
Sample Size Calculation – Power your study for conclusive results
Adaptive & Bayesian Designs – Flexibility without compromising integrity
Clinical Development Optimization
Phase I-IV Strategy – Efficient pathways for faster approvals
Risk-Based Monitoring (RBM) – Focus resources where they matter
Protocol & Study Design
Regulatory-Ready Frameworks - Compliant SAPs aligned with ICH/FDA/EMA requirements
Endpoint Strategy - Clear definition and documentation of all analysis objectives
Transparent Methodology - Pre-specified techniques for primary, secondary and exploratory analyses
Submission-Optimized - Audit-ready documentation to support regulatory reviews
Randomization & Blinding
Stratified/Dynamic Randomization
Blinding Strategies
Advanced Analytics
Survival Analysis, Mixed Models
Real-World Evidence (RWE)
