TLFs

SCiAN has the experience and core competency in programming tables, listings and figures in support of:

• Final analyses
• Interim analyses
• DSMB meetings
• Annual safety updates / DSURs
• Integrated summaries of safety (ISS)
• Integrated summaries of efficacy (ISE)
• Abstracts/Manuscripts
• Post-hoc and exploratory analyses

The source data for TLF programming are the raw (native) study database, SDTM or ADaM datasets.

All TLF programming is based on the shells created from the statistical analysis plan (SAP).  If shells are not available, SCiAN will create the shells upon request to ensure transparency and consistency of the output.

All programming is done by Programmer Analysts or Statisticians per the statistical analysis plan and TLF shell.  SCiAN’s SOPs defines a separate program to be developed for each individual TLF.

SCiAN maintains a STAT QC Tracker and Log for each study.  The Tracker and Log defines the extent and scope of quality control for TLFs.  QC includes independent programming, and/or code review and/or content review of a subset of programs and/or TLF output.  All issues are documented and resolved in the log.