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- Biostatistics activities are performed by senior or junior Statisticians: each step of the process is validated by the Biostatistics Manager before being presented to the sponsor.
- Biostatistics department offers internal and external resources (outsourcing).
- All statisticians are trained to the Biostatistics Standard Operating Procedures and involved in the updating of these procedures.
- ASCOPharm Biostatistics department guarantees a high level of quality in the following tasks:
- Methodology advice
- Formulation or validation of statistical section of protocols
- Sample size calculation
- Randomization list generation
- Statistical analysis plan
- SAS programming (Base, Stat, Macro, Graph)
- Statistical report
- Integrated Clinical report
- Summary of all statistical methodologies and results
Our current activities involve Phase II, III, IV studies and epidemiologic surveys:
VIH, Oncology, Kidney graft, Ophthalmology, Assisted medical procreation, Iron deficiency, Sleep pathologies…
For clinical studies, all of our documents (analysis plan, reports) are ICH-compliant. For Epidemiologic surveys, those documents are adapted following the project requirements. |
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