OUR SEVICES
We Provide a wide-range of statistical services including study design, data analysis, strategic advice and training.
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Clinical Development - Pharma and Medical Devices
- Support clinical development planning
- Provide inputs to study protocol and statistical analysis plan (Study design, choice of endpoints, sample size, appropriate statistical analysis methodology)
- Apply innovative study designs (sample size reassessment, interim analysis, etc.)
- Data analysis and interpretation of results
- Interactions with regulatory agencies
- Assists with CRO selection and oversight
- Support to publications
- Due diligence
Non-Clinical Development - Pharma and Medical Devices
- Statistical analysis of assay/bioassay qualification and validation
- Process development and optimization using Quality by Design methodology (Risk assessment and risk management, Design of Experiments; Failure Mode and Effect Analysis)
- Analytical product characterization (particle size distribution, water content, dissolution, flowability, etc.)
- Pre-clinical (animal) studies – pharmacology and toxicology
- In-vitro studies
- Manufacturing activities – statistical process control (SPC); repeatability and reproducibility (R&R) studies
- Stability studies
- Immunogenicity testing
- Process and product validation, performance testing
Training
We focus on promoting statistical thinking with examples that relate to practical considerations that go beyond statistics. Our training programs can be tailored to meet your needs, covering these topics or other ones as required.
General statistics
- Confidence intervals, statistical tests, determination of sample size
- ANOVA and Regression models
- Design of experiments (DoE)
- Process capability and statistical process control (SPC)
Clinical studies
- Types of studies (equivalence, non-inferiority, superiority, crossover etc.), selection of end-points and their proper analysis
- Adaptive designs and interim analysis
- Additional study related topics: multiplicity, survival analysis, missing data, meta-analysis
Non-Clinical
- Immunogenicity studies and bioassays
- Stability analysis and determination of shelf-life
- Validation of process, product and analytical methods, tech transfers
Statistical Services to Other Sectors
Although our focus is on providing statistical support to pharma and medical devices, we gained experience in other areas which may be relevant to your business, including
- Healthcare and medicine
- Chemical and food
- Electronics and micro-electronics
- Life sciences: genetics, zoology
- Renewable energy
- Military and homeland security
- Finance
- Agriculture