Clinical evidence problems. Solved.

Independent clinical research consultant. Ph.D., 18+ years in medical devices. EU-MDR, FDA, ISO 14155. I write the documents, run the analyses, and build the evidence strategies that get you through audits and into markets.

Get in TouchHow I Can Help
Dr. Marc Harms — Clinical Research Consultant for Medical Devices

How I Can Help

“Most clients start with one problem. The best outcomes come from connecting the evidence across the full product lifecycle.”

01Pre-Market
02Post-Market
03Commercialization
Pre-Market

Clinical Strategy & Study Design

“When business reality meets scientific rigor”

Regulatory approval requires clinical data — but resources are finite. A single study with 50 patients cannot simultaneously power a primary efficacy endpoint, a non-inferiority comparison, health economics outcomes, and three secondary objectives. I identify these 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.

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Post-Market

Post-Market Clinical Roadmap

“You're on the market. Now what?”

EU-MDR post-market obligations require a coherent strategy — not isolated documents. CER updates, PMCF activities, vigilance processes, and PMS reporting must form an integrated system tied to your actual evidence base. I structure the post-market clinical roadmap around a claims matrix: which technical, clinical, and regulatory claims are supported by evidence, where gaps exist, and what activities are needed to close them.

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Commercialization

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. But field teams often lack the scientific literacy to interpret it correctly, contextualize it against competitor publications, or stay within regulatory boundaries when discussing clinical outcomes with physicians. I run a structured evidence-to-field program that translates your evidence base into scientifically accurate, regulation-compliant field communication — not conventional sales coaching.

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The Claims Matrix

Every post-market deliverable starts from one question: what can you claim, and what evidence supports it?

T

Technical Claims

Performance specifications, bench testing, biocompatibility, design verification

+
C

Clinical Evidence

Clinical data, literature, PMCF results, systematic reviews, meta-analyses

=
R

Regulatory Compliance

CER, PMCF plan, PMS report, vigilance SOPs, claims substantiation

Technical Claims + Clinical Evidence = Regulatory Compliance — the matrix maps every claim to its evidence source and identifies gaps.

Learn more about the Claims Matrix
Strategic Intelligence

Intelligence Reports & Due Diligence Research

“The same analytical rigor applied to business questions.”

Not management consulting — clinical evidence intelligence. I assess competitors, acquisition targets, and new markets through the lens of published clinical data, regulatory filings, and evidence quality. The difference: the person reading the studies can actually appraise their methodology. Deliverables are traceable intelligence reports built on verified public-source data — not slide decks of opinions.

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The Solo-Expert Model

Large consultancies and CROs do excellent work. The difference is structural: when one person connects the dots across your entire evidence strategy, nothing falls between the cracks.

Aspect
Multi-Person Team
MH-Analytics
Who does the work
Team of specialists — you coordinate between them
One senior consultant — same person from scoping to delivery
Cross-document consistency
Separate authors for CER, PMCF, PMS — alignment by review
Single author connecting claims matrix, CER, PMCF, and PMS
Statistical analysis
Biostatistician works from brief, may not see the full picture
The analyst who runs the statistics also writes the CER
Evidence strategy
Defined per document or per project phase
Integrated roadmap across the full product lifecycle
Field communication
Separate sales training vendor, different knowledge base
Same scientist who built the evidence translates it for the field
Handoff risk
Knowledge transfers between team members at each phase
Zero handoffs — nothing gets lost between phases

Latest Insights

Perspectives on clinical evidence, regulatory strategy, and medical writing

December 28, 2025

Time Series Forecasting for Critical Systems: Building Reliable Predictions with ARIMAX

A practical guide to ARIMAX modeling for forecasting critical infrastructure, demonstrating how classical statistical methods deliver transparent, validated predictions—illustrated with German gas storage forecasting.

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December 15, 2025

Forest Plots in R with metafor: From Basic to Publication-Ready

A hands-on guide to creating forest plots in R using metafor — from simple plots to publication-ready figures with heterogeneity stats, prediction intervals, and detailed study-level annotations.

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December 10, 2025

Beyond the Standard Model: Multilevel and Multivariate Meta-Analysis for Complex Clinical Evidence

A practical guide to multilevel and multivariate meta-analytic models — handling dependent effect sizes, correlated outcomes, longitudinal data, and arm-based analyses in clinical research.

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Explore Science & Methods

Credentials

  • Ph.D. in Natural Science (Chemistry & Materials Science)
  • 18+ years in clinical research and regulatory affairs for medical devices
  • Published in peer-reviewed journals (JSES, Journal of Pediatric Surgery, Angewandte Chemie)
  • Biostatistics certification (2022–2023)
  • Statistical analysis in R / RStudio
  • Core methodologies: systematic reviews, meta-analysis, clinical study design
  • Regulatory frameworks: ISO 14155, EU-MDR, IVDR, 21 CFR 812, ICH E6(R2)/GCP
  • Direct expert access — no junior team, no subcontracting
Publications & BlogRead the methodology behind the work

About Dr. Marc Harms

How I Work

When you hire MH-Analytics, you get me — a senior scientist with 18+ years of experience — at every stage. I don't hand off work to juniors and I don't subcontract. That means you get consistent quality and direct access to the person who actually does the work. It also means I'm selective about projects. I take on work where my expertise makes a real difference, not everything that comes through the door.

Why This Range

My work spans systematic reviews, meta-analysis, ISO 14155 clinical investigations, post-market surveillance, and sales enablement. That range is unusual — and deliberate. Clinical evidence only creates value when it connects to regulatory approval, post-market compliance, and commercial success. Most consultancies split these across different departments. I keep them in one head.

Background

Ph.D. in Natural Science (Chemistry & Materials Science). 18+ years in clinical research and regulatory affairs for medical devices. Published in peer-reviewed journals. Biostatistics certification. Based in Moers, Germany. I work with medical device companies across Europe — from study design and protocol writing through clinical evaluation, post-market strategy, and evidence translation for the field.