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Consulting

No matter your problem, we can tailor a solution.

Tailored to you needs - Leverage our expertise in

Non-Clinical 

  • Bioassay: development, validation,techniques for parallelism, bridging,etc.
  • QbD & Design space: Risk-based, predictive design space
  • Lifecycle Process Validation: leading experts in the latest regulatory PV expectations, and how to adapt to meet them while reducing risk and complexity
  • Bayesian solutions: we are the experts in applied Bayesian solutions, used when appropriate
  • Assay design & validation traditional validation/transfer, total error approach, QbD and design space for analytical methods, and more
  • Training: we provide training in applying statistics to your business, from basic statistics through Bayesian modeling; training is tailored to your audience (scientists, QA, statisticians, engineers, etc.)
  • Biomarkers: simplify and improve validation of biomarkers
  • DOE: we can help by providing state-of-the-art, efficient DOE
  • SPC: we know how best to apply SPC to your processes, to reduce complexity and improve process understanding
  • Scale-up/scale-down modeling connect your process end-to-end and from small to large scale, using the right statistics to most efficiently move to commercial scale

Clinical

  • Translational science: integration of laboratory and clinical information to optimize patient sample size
  • Model-based drug developement: optimization of your move from preclinical to early clinical and the design of your trial, including PK/PD modelling, analysis and reports
  • Adaptive designs: construct adaptive designs, optimization of your decision criteria and simulations of multiple scenarios
  • Clinical trials predictions optimized go/no-go decision process thanks to custom-made tools based on Bayesian methodology
  • Protocols & reports protocol writing, design of statistical analysis plan (SAP), programming of your TFL (Tables/figures/listings) and input in your clinical reports

 

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

What makes us different