How I Can Help
Clinical evidence only creates value when it connects to regulatory approval, post-market compliance, commercial success — and the internal workflows that produce it. I keep all of that in one head.
Clinical Strategy & Study Design
“When business reality meets scientific rigor”
Regulatory approval requires clinical data — but resources are finite. I identify design conflicts early, align the statistical framework with what the data can realistically support, and develop a protocol that satisfies regulatory requirements within your actual budget and timeline.
Typical Deliverables
- —Clinical research strategy
- —Study design & protocol (ISO 14155)
- —Sample size estimation & SAP
- —Systematic literature reviews
- —Independent statistical analysis (R)
Post-Market Clinical Roadmap
“You're on the market. Now what?”
EU-MDR post-market obligations require a coherent strategy — not isolated documents. I structure the post-market clinical roadmap around a claims matrix: which claims are supported by evidence, where gaps exist, and what activities are needed to close them.
Typical Deliverables
- —Claims matrix development
- —Clinical evaluation plans & reports (CEP/CER)
- —PMCF plans, surveys & evaluation reports
- —PMS strategy & vigilance SOPs
- —Complete clinical research SOP systems
Evidence-Based Field Communication
“Your reps have the data. They just can't use it.”
Your clinical evidence exists — in CERs, published studies, or post-market data. I run a structured evidence-to-field program that translates your evidence base into scientifically accurate, regulation-compliant field communication.
Typical Deliverables
- —Evidence-to-field translation
- —Product & indication evidence dossiers
- —Training workshops (live & virtual)
- —Key clinical question mapping
- —Quick-reference evidence cards
Operations & Workflow Optimization
“Your evidence is only as good as the workflows that produce it.”
Studies, documentation, and SOPs often outgrow the spreadsheets and shared folders that hold them. I bring structure to how clinical work is run — so the same rigor that makes your evidence defensible makes your operations efficient and audit-ready.
Typical Deliverables
- —Investigator-Initiated Study (IIS) management
- —Process automation
- —Medical writing & study documentation
- —SOP audits & revisions
- —Document & system templates
Ready to discuss your project?
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