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 As regulatory authorities are requesting increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programs. Creascience provides a range of services from the planning, the analysis to the reporting of clinical trials to the biotech and the pharmaceutical industry for the scientific evaluation of new prototypes, treatments and diagnostic tests.
Drug Development
- Design of efficient laboratory experiments and studies
- Procotol development: Statistical methods sections of protocols
- Sample size (number of subjects) and power determination
- Randomization
- Data validation
- Data analysis and reporting
Diagnostic Test Development
- Developing efficient diagnostic tests
- Sampling plans
- Test validation: reproducibility, concordance, accuracy, sensitivity and specificity
- Dealing with the absence of a gold standard
- Sample size and power determination
- Data analysis and reporting
Biostatistics in Manufacturing Processes
- Process monitoring and adjustments with statistical control techniques
- Sampling plans
- Design and analysis of stability studies
- Data analysis and reporting
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