• Design and management of databases collected from clinical studies (Data management)
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– Design of the CRF in electronic format in e-CRF
– Importation of data into electronic databases
– Data control and management of inconsistencies in the data entered
– Extraction and transference of data from the database
    • Definition of statistical tools
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– Analysis/development of the experimental plan and the working hypotheses in collaboration with the doctors/veterinarians
– Researching on the subject of the study
– Definition and development of adequate statistical methodologies to be applied in clinical studies
– Calculation of the number of patients needed for the study
– Development of the randomization list of patients
– Development of the statistical part in the study protocol
– Design of the statistical analysis plan
    • Statistical analysis
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– Management of databases and creation of derived databases
– Program statistical analysis using SAS ® software (SAS/BASE, SAS/MACRO, SAS/ODS, SAS/SQL) or R
– Creation and validation standards macros under SAS® or R
– Application of advanced statistical methods: inferential statistics (parametric and non-parametric), linear regression, analysis of variance, mixed models, generalized linear models, survival models.
    • Report and outputs
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– Generation of outputs under SAS®: tables, listing, figures.
– Interpretation and presentation of the statistical results of clinical studies
– Development of the statistical report
– Preparation of publications, posters and abstracts
    • Validation of the quality and proper processing of data from clinical and preclinical studies
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– Ensuring quality and integrity of statistical programs to meet current regulatory requirements and industry standards
    • Validation of SOPs (standard operating procedures)
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– Contribution to the development of SOPs in agreement ICH-GC