Statistical Programming

Implement statistical analysis plans into current FDA-accepted formats.

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 to data query, database edit checks and creation of analysis datasets.
  • Creation of TLGs for interim analyses, Data Monitoring Committee (IDMC), clinical study reports and integrated summary report (ISS/ISE).
  • Pharmacokinetic and pharmacodynamic data analysis and modeling.
  • Analysis and reporting of pre-clinical data.
  • Statistical programming consultation to clinical research and marketing support professionals.
  • Prepare e-submission package
    • CDISC implementation
    • Legacy data creation to SDTM
    • Annotating CRF pages
    • Define.pdf or Define.xml
    • Study data reviewer’s guide
    • Analysis Data reviewer’s guide
    • Submission of XPT datasets
    • Submission of programs
    • eCTD Module 5 preparation