Clinical Development
September 18, 2026Advanced Analytics
September 20, 2026
High-quality data. Sound methods. Reliable code.
InCSD provides biostatistical consulting, statistical programming, and clinical data management support to pharmaceutical and biotechnology sponsors. Our expertise spans clinical trial design, statistical methodology, analysis planning and interpretation, data standards, programming, data quality, and statistical support for regulatory submissions.
Our Biometrics Capabilities
- Statistical strategy, methodology, and clinical trial design
- Endpoint and estimand specification
- Sample size, power, and operating characteristics evaluation
- Randomization, allocation, and blinding specifications
- Statistical analysis plans (SAPs)
- Statistical analysis, interpretation, and sensitivity analyses
- Missing-data methods and analysis-population specifications
- Statistical contributions to clinical study reports and regulatory submissions
- CDISC SDTM and ADaM specifications and datasets
- Analysis dataset development and validation
- Tables, figures, and listings (TFLs), including mock shells
- Define-XML and associated metadata deliverables
- Data traceability and submission readiness
- Independent programming QC and validation
- Programming automation and reproducibility
- Data management planning and oversight support
- CRF/eCRF design and edit-check specifications
- Data transfer specifications and review
- Clinical data review and query-management support
- External data reconciliation and quality assessment
- Database lock readiness and data integrity review