Biostatistics and Programming Solutions, Unlocking the Power of Data for Healthcare Advancements.
CDISC Standards Implementation
- Conversion of raw data to CDISC
- SDTM (Study Data Tabulation Model)
- Creation of ADaM (Analysis Data Model) datasets
- Document metadata for regulatory submission(P21 report, S/ADRG, define.xml)
Statistical Analysis and Reporting
- Study-specific statistical analyses
- Creation of summary tables, listings, and graphs
- TLF (Tables, Listings, Figures) generation
- Safety and efficacy analysis
Clinical Trial Reporting
- Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
- Clinical Study Reports (CSRs)
- Regulatory submission support
- Patient Profiles
Quality Control and Validation
- Validation of programming code and results
- Review of output for accuracy and consistency
- Quality assurance of deliverables