Contribution/Services

Details

Category: Kategorie1

Published: Thursday, 31 December 2015 10:48

Written by Super User

Hits: 12209

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

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