Customized Biostatistical Analysis for Clinical Trials
No matter how complex your clinical trial is, we tailor our advanced biostatistical analysis services to deliver optimal data analysis and interpretation across all therapeutic areas, study phases, and milestones.
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Design
- Innovative trial design
- Designing and writing the protocol’s statistical section
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Setup
- Biostatistician review of the CRF
- Randomization list and randomized kit list creation
- Randomization algorithm validation
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Conduct
- Statistical analysis plan creation
- DMC Charter
- Monthly randomization checks
- Creation of ADaM derived datasets
- DSUR analyses
- SAS programming and independent verification of tables, listings, and figures
- Interim analyses
- Futility analyses
- DMC preparation and attendance
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Analysis
- Final ADaM datasets and associated documentation
- PK/PD analyses
- Final tables, listings, and figures
- Integrated summaries of safety and of efficacy (ISS, ISE)
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Report & Publication
- Statistical appendices in accordance with ICH E3 guideline
- Statistical review of clinical study report (CSR)
- Statistical inputs to publications
- Statistical sections of FDA/EMA submissions
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Other Analyses & Support
- Meta-analysis
- Validation of surrogate endpoints
- Exploratory analyses
- Biomarker-IVD validation
- Support with regulatory bodies
Whether we’re interacting with regulatory bodies on your behalf or deploying standard and innovative statistical methods recommended by regulatory agencies, our advanced biostatistical analysis turns your data into clear, actionable insights.
