IDDI provides biostatistical services for trial design, conduct, analysis and reporting.
The biostatistics department is one of most important contributors to clinical development programs, ensuring optimal protocol and trial design, also performing trial simulations.
The department also has extensive experience with Data Safety Monitoring Boards, its charter development, logistics and safety and efficacy analyses.
Statisticians are experienced in providing analyses both for study reports and publications.
IDDI has a very strong team of biostatisticians who account for about a third of its employees.
IDDI provides assistance to its Sponsors when presenting results at the FDA and EMEA.
IDDI's experience on Statistical Analyses of Biomarkers and Gene Expression Profiles
Biostatistics services provided by IDDI are:
- Protocol design
- Biomarkers qualification/validation
- Clinical use of gene profile
- Statistical analysis plan
- Derived datasets
- Programming and production of tables, listings, graphs
- Risk Assessment
- Statistical report + appendices
- Validation of stats work; audits
- Meta-analyses
- Exploratory analyses
The final statistical analysis contains all tables, listings, descriptive statistics, graphs, and statistical tests required to interpret the trial results. These are defined in a statistical analysis plan. Analysis of open label trial results are provided on a continuous basis to give an optimal status throughout the study. Statisticians use state-of-the-art software such as SAS® or S-plus® in addition to specialized software such as StatXact®, EaSt® ,etc.