Biostatistics
Turning study data into meaningful, statistically sound conclusions.
At CORONIS Research, we believe that every successful clinical trial begins with robust statistical planning.
Our Biostatistics team provides expertise from protocol design through data interpretation, ensuring that every analysis is methodologically sound, regulatory-compliant, and aligned with your study objectives.
Our Core Biostatistics Services include:
Sample Size Calculation
Accurate sample size determination is essential to achieving valid and reliable study outcomes.
CORONIS’s biostatisticians perform precise sample size and power calculations based on study design, endpoints, and variability assumptions.
We assess feasibility, detectability of treatment effects, and ensure adequate statistical power while maintaining cost efficiency.
Our tailored calculations help sponsors optimize recruitment targets and resource planning — avoiding underpowered or overextended studies.
Randomization
Robust randomization ensures objectivity and eliminates bias across study arms.
Our experts design and generate randomization schedules appropriate for each study’s design — including simple, block, stratified, or adaptive randomization methods.
We coordinate implementation in collaboration with your clinical and data teams, ensuring confidentiality, traceability, and reproducibility.
This guarantees a balanced and unbiased allocation process that meets both protocol and regulatory expectations.
Statistical Analysis Plan (SAP)
A clear and comprehensive Statistical Analysis Plan guides every analysis decision.
CORONIS develops detailed Statistical Analysis Plans (SAPs) that define statistical methodologies, data handling rules, and analysis populations.
Our SAPs are prepared in accordance with ICH-E9 and regulatory guidelines, ensuring transparency and reproducibility of statistical results.
Each SAP is tailored to the study’s endpoints and objectives, serving as the blueprint for reliable and compliant data analysis.
Statistical Analysis & Reporting
Delivering clear, accurate, and regulatory-ready results.
Our biostatistics team performs comprehensive statistical analyses across all study phases — from exploratory to confirmatory and post-marketing research.
We generate clear, well-documented outputs, including tables, listings, and figures (TLFs), interim reports, and final statistical summaries ready for clinical study reports (CSRs) and regulatory submissions.
Our analytical work is performed using validated software and compliant workflows, ensuring precision, traceability, and interpretability.