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Biostatistics

Biostatistics

Vita Eterna offers the main range of decision-making services from the point of view of statistical analysis for all stages of clinical trials and non-interventional observational studies.

Services:

  • Statistical support on all stages of clinical trials Statistical aspects of clinical trial design on stages I-IV and observational trials
    - Selection of trial design for Stage I trials
    - Selection of trial design for Stage II-III trials and design and sample selection for

    observational studies (cohort, case-control, panel, complex survey design - cluster sampling,

    time-location sampling, respondent-driven sampling)
    - Discussion of preferable endpoints
    - Support for adaptive trial designs
    - Sample size calculation for different types of endpoints in fixed sample and adaptive

    trials
    Statistical input to study Protocol
    Randomization services with different randomization approaches (simple, block, stratified, unequal) Statistical Analysis Plan (SAP) Interim statistical analysis (blinded and unblinded) Statistical Report and Statistical chapters in Integrated Clinical Trial Report Generation of TLF and shell TLF for (SAP) Statistical analysis and planning of non-inferiority studies Statistical aspects of BE and generally PK/PD studies (planning and analysis) Full range of Statistical methods employed
    - parametric and non-parametric statistics
    - robust statistical methods
    - different types of regression and mixed models
    - survival analysis (parametric and non-parametric)
    - support of exploratory trials and clinical database analysis (including classification and regression trees and neural nets for classification tasks)
    - statistical analysis of complex survey designs (cluster sample, respondent-driven sample) and cluster randomized trials Visualization
    - Different types of clinical graphs, including AE time course graphs
    - On-demand map plotting
    - General graphs and support for clinical trial and observational study presentation

    Instruments used:
    Validated Installation of Microsoft Open R (base/stat) with additional modules installed after validation On-demand SAS programming with set of validated macro

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