Genelife Clinical Research offer excellence in SAP writing through final analysis reporting.
The Biostatisticians at Genelife Clinical Research have extensive experience with ICH E9 as well as analysis and reporting of clinical trial data. We at Genelife develop the statistical analysis plan (SAP), design all required tables, listings, and graphs, and provide final output of all clinical trial data and final analyses. Our experienced statisticians also provide insight into the need for expanded analyses in order to clarify a trial’s outcome with respect to all endpoints evaluated.
For randomization we have developed a computerized central randomization system that fully validated and 21 CFR, Part 11 compliant. This central Randomization system provide rapid, and secure access to randomization. This is 24 hour online facility through which investigators can generate randomization code.
The services provided by Genelife are:
- Preparing statistical aspects of clinical protocols including development of study design, sample size calculation, and formulation of statistical analysis section of protocols
- Preparing Patient Randomization and Blinding Plan
- Co-ordination of Code-breaking
- Developing Statistical Analysis plan for individual studies
- Generating Data listings and Tabulations for demographic, efficacy and safety data
- Designing tables and graphics
- Statistical analysis, reports and synopsis