Expert Clinical Biostatistics services for clinical trials provided by IDDI include:
- Protocol Design
- Statistical analysis plan
- Derived datasets
- Programming and production of tables, listings, graphs
- Statistical report and appendices
- Validation or audits of stats work accomplished by others
- Exploratory analyses
- Biomarkers validation
IDDI has a very strong team of biostatisticians who account for a third of its employees and include numerous PhDs.
The biostatistics department is one of the most important contributors to a clinical development program, ensuring optimal protocol and trial design as well as performing trial simulations and study analyses.
All studies are performed in compliance with FDA and CDISC requirements.
Our SDTM/ADaM experts have the ability and experience in developing eCRF’s to CDISC/CDASH standards and delivering data in STDM and ADaM standards.
The department also has extensive experience with Data Safety Monitoring Boards, including charter development, and generating safety and efficacy analyses.
Statisticians are experienced in providing analyses both for study reports and publications.
IDDI provides assistance to Sponsors when presenting results to the FDA and EMA.