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Added value
- Double programming for efficacy and safety criteria
- Statistical expertise
Biostatistics
Services
- Sample size calculation.
- Randomization list creation and distribution (e.g. using an assigned secure website).
- Participation in the statistical parts of protocol and Clinical Study Report writing.
- Preparation of the Statistical Analysis Plan in accordance with the chosen procedures; Customer or DELTA CONSULTANTS, and with GCP, ICH and EMA guidelines.
- Results programming and analysis by the biostatistics team.
- Statistical report writing.
- Presentation of study results.
- Software used SAS®
Consulting
DELTA CONSULTANTS also offers a consultancy service providing critical review of statistical analysis parts of protocols, Clinical Study Report or publications and advice on statistical methodology.
An analytical mind
Having a solid statistical background, DELTA CONSULTANTS biostatistics team handles all methods necessary for study statistical analysis: descriptive statistics, parametric or non parametric tests, equivalence and non-inferiority tests, comparisons and multiple tests, generalized linear models, nonlinear models, mixed models, survival analysis, meta analysis, descriptive and multivariate explanatory analyses to understand the population structure and to identify prognostic factors.
