Prove efficacy & effectiveness
Biostatistics is the core to prove efficacy and effectiveness in every clinical trial with statistical analysis.
From study design, protocol development, data collection, and analysis to the final reporting, biostatisticians play a key role in each step!
“Our robust integration and collaboration between statisticians and clinical operations team ensure that clinical trials led by HEMEX are efficiently designed with a high-quality data analysis. It is exciting to observe how clinical research data turns into real solutions.“
1/4
Study design
Statistical design is required to prepare documents and study protocol.
2/4
Implementation
Maintenance and tracking of clinical study data stored in the Trial Master File (TFM).
3/4
Analysis
Interim analysis and reporting. Statistical analysis is required in
this phase.
4/4
Submission
Results are
submitted to agencies
(FDS, EMA).
Statistical Design
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When preparing a clinical trial, the hypothesis and study endpoints must be determined. Our experienced biostatisticians can provide essential statistical input and help develop a lean and efficient study design.
The data needs to have enough statistical power to validate the study results. Sample size and power calculations will provide an adequate number of participants/samples needed in each clinical trial.
Data is the heart peace of each clinical trial. Design of data collection forms, on-site/remote monitoring, and export of datasets are all supported by us.
HEMEX develops a complete statistical analysis plan obligatory for a clinical trial!
Statistical Analysis
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High-quality data analysis is a crucial component of a clinical trial. Biostatisticians at HEMEX carefully check the datasets to provide a clean export.
HEMEX works with advanced statistical methods like descriptive & inferential statistics, correlations & regressions, survival analysis, or machine learning algorithms and provides clear and easily understandable results.
The statistical analysis outcomes are presented in an accurate set of figures and tables.
HEMEX delivers high-quality reports with statistical input in collaboration with medical writing.
“Every day, the whole HEMEX team works hard to make an impact in future healthcare. We have an excellent track record of successful life sciences projects because the quality of our work is vital for us.”
Our Solutions
We provide full-service on Biostatistics.
- Study Design
- Choice of Endpoints
- Adaptive Design
- Sample Size Calculation
- Meta Analysis
- Statistical Input
-
Validation for Surrogate Endpoints
- Pharmacokinetic Analysis
- Statistical Analysis Plan
-
Statistical Tables, Listings and Figures
-
e/CRF Design and Reviews
-
Protocol Development
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