Contribution/Services

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Pharma/Clinical Trials

  • Statistical protocol development / Study plan
  • Statistical Analysis Plan (SAP)
  • Analysis Quality Plan
  • Interpretation of Analyses
  • Publication support /Abstracts, Poster, Presentations
  • Statistical review of publication manuscripts
  • Meta analyses – study pool analyses/ safety and efficacy
  • Statistics for Integrated Summary of Safety
  • Statistics for Integrated Summary of Efficacy
  • Exploratory post-hoc analysis of ‘failed’ studies

 

Pharma/personalized health care

  • Exploratory and confirmative biomarker analysis
  • Development of multi-parameter decision rules
  • Tailored scoring of pathological tissue readings
  • Support of companion diagnostic development
  • Innovative designs for statistical testing of non validated biomarker decision rules

 

Pharma/Marketing

  • Pooled analyses/exploratory for efficacy or safety
  • Literature analyses (Meta analyses)
  • Publication support
  • Poster Development

 

Diagnostics

  • Measurement accuracy assessment
  • Measurement equivalence studies in platform changes
  • Clinical utility studies / Marketing studies
  • Publication Support
  • Cutoff search / decision functions
  • Companion diagnostics development
  • Automated Image Analysis/FISH scoring

 

Scientific Quality Assurance

  • Critical review of protocols
  • Critical review of analysis plans
  • Critical review of reports/ publication manuscripts
  • Team discussion of analysis interpretations
  • Correct result messaging