Biostatistics
IDDI has a very strong team of biostatisticians who account for about a third of its employees. The biostatistics department is one of most important contributors to clinical development programs, ensuring optimal protocol and trial design as well as performing trial simulations.
The department also has extensive experience with Data Safety Monitoring Boards, including charter development, organization and logistics as well as generating safety and efficacy analyses.
Statisticians are experienced in providing analyses both for study reports and publications.
IDDI has extensive experience in providing assistance to Sponsors when presenting results at the FDA and EMA.
IDDI's experience on Statistical Analyses of Biomarkers and Gene Expression Profiles
Biostatistics services provided by IDDI are:
- Protocol design
- 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
- Biomarkers qualification/validation:
Advances in molecular biology, high throughput technologies and imaging techniques provide investigators with an ever-growing number of biomarkers which are already used for a variety of purposes: to take early go/no go decisions in drug development, to stratify patients, to target "responding" subsets, to adjust treatments for individual patients, or to replace clinical endpoints for decision making. Here too IDDI involves challenging statistical issues in identifying and validating biomarkers that have prognostic and/or predictive ability, or those that can potentially be used as surrogate endpoints in clinical trials.
Project references are available upon request.
Statisticians use state-of-the-art software such as SAS® or S-plus® in addition to specialized software such as StatXact®, EaSt® ,etc.