Biostatistics Services

We are offering expert statistical support backed by deep therapeutic knowledge and regulatory compliance. Our experienced statisticians and SAS programmers adhere to global standards such as:

  • cGCDMP
  • 21 CFR Part 11
  • CDISC/CDASH
  • SDTM & ADaM
  • HIPAA
  • ICH & Global Regulatory Guidelines
biostatistics-services

Core Biostatistical Services

  • Study design consultation
  • Sample size calculations
  • Randomization schedule generation
  • Blinding and unblinding procedures
  • Statistical input for clinical protocols
  • Statistical Analysis Plan (SAP) development
  • Interpretation of statistical outcomes
  • Stand-alone statistical report writing

Statistical Programming Services

  • SAS programming following CDISC SDTM & ADaM standards
  • Generation and validation of Tables, Listings, and Figures (TLFs/TLGs)
  • Interim and final statistical analysis
  • Creation and validation of CDISC-compliant datasets
  • Integration of data across multiple protocols
  • Data derivation and CDISC mapping
  • Program validation and documentation