Professional Expertise in Biostatistics
Our offer:
First-class statistics for medical research.
We support clinical studies from the initial idea to publication. We get involved earlier than a traditional CRO – and think more strategically than a freelancer.
WHO WE WORK FOR
Oncology & CNS: Investigator Initiated Trials
External statistics partner for research groups
For academic research groups that require a complete statistical service – with the reliability of a CRO and the flexibility of a personal partner.
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Study design & protocol
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Case number planning
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Randomization
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Statistical Analysis Plans (SAP)
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Primary and secondary analyses
Extensive experience in Phase II/III trials, particularly in breast cancer research and biomarker-driven designs.
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Survival analysis, mixed models
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DSMB / IDMC Participation
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Statistical Reports
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Methods & Results sections for publications
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Biomarker analyses
Biotech & Pharma
Fractional VP Biostatistics
For biotech companies that don't have their own statistics department – but need an experienced senior statistician who thinks strategically, manages the CRO and acts as an internal voice.
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Strategic study planning
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Design of biomarker-driven studies
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Oversight & Control of External CROs
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Regulatory communication (EMA, FDA)
We know the CRO side from the inside – that makes our oversight more effective.
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SAP Review & Quality Assurance
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Precision Medicine / CDx
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Interim analysis, adaptive design
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Internal training & consulting
Digital Health - DiGA
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SAP creation
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Statistical analysis
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Results report for BfArM
DiGA study package
For manufacturers of digital health applications who need to provide proof of benefit – all from one source, from planning to analysis.
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Study design for DiGA studies
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Case number planning
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Endpoint specification
Extensive experience with DiGA-specific requirements and regulatory standards.
HOW WE WORK
01
Concept & Design
Early start – we design the study together with you.
02
Planning & Protocol
Sample size, randomization, SAP, mock tables – all GCP and ICH compliant
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Analysis & Reporting
Primary and secondary analyses, professional graph, official reports.
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publication
Methodology and results sections for scientific publications.
"By using modern AI-supported workflows, we deliver SAPs and analyses faster – without compromising quality or regulatory compliance. Our senior statistician always retains professional responsibility."
Statistical methods
Survival Analysis
Kaplan-Meier
Cox Regression
Competing Risks
Longitudinal models
Mixed Models
GEE
Longitudinal
Biomarkers & Genomics
Polygenic Scores
Subgroup analyses
CDx
Modern methods
Machine Learning
Meta Analyses
Adaptive Designs