Sample size calculations
Robust power and sample-size estimates aligned to study objectives.
Overview
Voxtur Clinical Research provides Biostatistics Services from the early stages of clinical study design through analysis and regulatory submission. Our biostatistics team supports sponsors with sample size calculations, endpoint selection and statistical analysis strategies based on the objectives and design of each study.
We develop Statistical Analysis Plans (SAPs), support interim analyses and Data Safety Monitoring Board (DSMB) activities, and prepare integrated safety and efficacy summaries. These services help turn clinical trial data into structured statistical evidence suitable for reporting and regulatory review.
Capabilities
Robust power and sample-size estimates aligned to study objectives.
Independent review and clear statistical reporting of study results.
Design and analysis consulting from protocol through submission.
Integrated summaries of safety and efficacy for regulatory dossiers.
Interim analyses and independent data safety monitoring board support.
Detailed, pre-specified analysis plans consistent with regulatory expectations.
Why Voxtur
Statistical input from the first protocol draft.
Analyses and summaries built for USFDA and EMA review.
Statistical deliverables aligned with data standards.
Complex results communicated clearly to reviewers.
Explore More
Speak with our team about how bio-statistical services can support your molecule and target markets.