The Statistical Programmers set up the analysis database, generate diagnostic data for centralised monitoring and outputs for interim analysis. Based on the statistical analysis plan they create the analysis files and reporting programs to produce tables, figures and listings for the clinical study report.
- Centralised monitoring reports
- SAS programming of offline data checks
- Internal safety review committee (iSRC) support
- Preparation of Clinical Data Interchange Standards Consortium (CDISC) compliant clinical trial data according to Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM) structure
- Compilation of safety and efficacy data, tables, listings and figures (TLFs) for regulatory submissions
- Clean file support