Full Range of Clinical Biostatistics Services
We provide advanced clinical biostatistics services for leaner and more efficient clinical trials. At IDDI, Biostatistics is at the heart of every clinical study—driving study design, protocol development, clinical data collection, analysis and reporting. Our expert consultants provide high-level strategic consulting services to optimize your clinical development strategy ranging from clinical trial design and protocol development to regulatory submission and FDA/EMA meeting representation. IDDI Adds Critical Thinking to Advanced Clinical Biostatistics.
From study inception to delivery of the clinical study report, our skilled biostatisticians are involved to increase efficiencies at every phase of your clinical drug development. Download our service sheet!
- Study design
- Adaptive designs
- Choice of endpoints
- Statistical analysis
- Statistical Analysis Plan
- Sample size calculation
- Trial simulations
- CDISC Standards: mapping SDTM into ADaM
- Data Monitoring Committees (DMCs) and interim analyses
- Meta-analysis
- Validation of surrogate endpoints
- Biomarker validation
- Translational research
- Key risk indicators – KRI
- Central Statistical Monitoring – CSM
- Statistical and strategic consulting
- Representation at the Regulatory Authorities
- Integrated summaries of safety and of efficacy
- (ISS, ISE or PASS, PAES) and statistical sections of NDAs/EU submissions