Implement statistical analysis plans into current FDA-accepted formats.

Statistical Programming

Frontage’s versatile statistical programming and analysis capabilities support clinical studies or standalone projects. We implement statistical analysis plans, deliver interim and final analyses, or convert legacy data into current FDA-accepted formats.

  • Development of SDTM/ADaM using CDISC standards
  • Statistical analysis and programming support for data queries, database edit checks and creation of analysis datasets
  • Creation of listings, tables and graphs for interim analyses, Data Monitoring Committee support, clinical study reports and integrated summary reports (ISS/ISE)
  • Pharmacokinetic and pharmacodynamic data analysis and modeling
  • E-submission package
    • CDISC implementation (SDTM/ADaM database)
    • Annotated CRFs
    • SDTM/ADaM Define.pdf or Define.xml
    • SDTM/ADaM Reviewer’s Guides
    • Legacy data conversion to SDTM
  • Analysis and reporting of pre-clinical data