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Biostatistics Services
Biostatistics Services is IDDI’s DNA and Core CompetenceAdvanced Statistical Methodology and Operational Excellence for Leaner and Faster Clinical Trials. Biostatistics is at the heart of every clinical study, driving study design, protocol development, clinical data collection, data analysis, and reporting. IDDI delivers optimal study designs, best practice randomization methods, regular independent checks of the randomization balance, CRF review, and timely statistical analysis in order to produce clinical trial results that are scientifically accurate, validated, and reproducible. Biostatistics is the backbone of the company. With scientific roots and in-depth clinical and regulatory experience, our team understands the scientific issues, anticipating and overcoming potential challenges specific to your clinical trial.
From study inception to delivery of clinical study report, our skilled biostatisticians are involved at all steps of the clinical trial process to increase efficiency of our clients’ clinical drug development. Our expert biostatisticians offer flexible and innovative solutions for clinical research, and are not afraid to challenge the status quo.
- Strategic Consulting Services
- Study Design
- Choice of Endpoints
- Adaptive Design
- Sample size Calculation
- Trial Simulations
- Validation of Surrogate Endpoints
- submissions
- Statistical input to publications
- Translational Research
- Biomarker-IVD Validation
- Meta Analysis
- Futility Analysis
- PK Analysis
- Statistical Analyses
- Statistical Analysis Plan (SAP)
- Data Monitoring Committees (DMC)
- Interim Analyses
- Randomization list and kit lists
- CRF Review
- Dry runs
- CDISC Standards: Mapping SDTM into ADaM
- Statistical Reports and Appendices
- TLF Creation
- Validation of Randomization Algorithms
- ISS, ISE
- Representation at the Regulatory Authorities (FDA/EMA)
Since IDDI’s creation in 1991, more than 350 pharmaceutical and biotechnology companies, as well as academic cooperative groups and CROs worldwide, have relied successfully on our expert biostatistics services, statistical consulting, operational excellence, unbiased expertise, independent data quality assessments capabilities and regulatory-compliant procedures to optimize the value of their clinical trials.
In-depth experience in a range of therapeutic areas, paired with profound understanding of ICH GCP, regulatory requirements and ADaM analysis datasets, ensures quality throughout all stages of drug development.
Our strong team of biostatisticians and statistical programmers produce high quality, reproducible, timely analysis and reporting of clinical trial results across all therapeutic areas. All of our statisticians and statistical programmers receive ongoing, intensive training inside and outside the company to deliver premium biostatistics and statistical programming services.
BIOSTATISTICAL SOFTWARES
- SAS or R programming
- Standard SAS reporting macros
- Specialized software for sample-size calculation and group sequential designs (EaST®)