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Biostatistics

Expertise in the design and analysis of clinical studies.

Expertise

Syntax for Science provides full service or independent biostatistical and statistical programming support. Our biostatisticians combine a comprehensive knowledge base of all aspects of clinical trials with advanced skills in SAS® programming.

Our validated computer system follows the appropriate ICH guidelines, particularly E9 (Statistical Principles for Clinical Trials) and E3 (Structure and Content of Clinical Study Reports), assuring secure and accurate data analysis.

Biostatistics Services:
  • Protocol and Statistical Analysis Plan development
  • Sample Size/Power Calculations
  • Interim analysis for early decision making and coordination of Data Safety Monitoring Boards
  • Randomization services
  • Preparation and review of essential study documents (e.g. CSP, SAP)
  • Pharmacokinetics and Pharmacodynamics analysis
  • Adaptive design consulting and simulation support
  • Centralize Statistical Monitoring
Programming Services:
  • Statistical Programming in SAS® of tables, listings and figures
  • Mapping of old studies to CDISC format (SDTM, ADaM)
  • Derived datasets
  • Statistical report and appendices
  • Validation or audits of stats work accomplished by others
  • Meta-analyses
  • Exploratory analyses
  • Biomarkers validation
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