Independent Clinical Research Consultancy
The Clinical Evidence Problem.
Solved.
Evidence that survives regulators, notified bodies, and your own due diligence. Systematic reviews, meta-analysis, clinical strategy — built personally, start to finish.
One person. One PhD. No handoffs.
How This 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.
Turn PDFs into audit-ready evidence tables
A PICO question and a batch of full-text PDFs go in. A grounded, source-linked extraction table comes out — every value traceable to its quote, section, and page.
Prompt
In patients receiving the study device, what were the primary safety and effectiveness endpoints reported at 12 months?
Suggested extraction fields
Describe the review question — the system derives the PICO framing.
Still managing IIS in Excel and SharePoint?
Most small and mid-size medtech companies track investigator-initiated studies across spreadsheets and shared folders — until something gets lost. There is a lighter way than an enterprise CTMS.
The spreadsheet reality
- IIS status scattered across spreadsheets, inboxes, and shared folders
- Missing contracts or reports found only during audit preparation
- Milestones and budgets tracked differently in every department
What the CTMS gives you
- One structured register: studies, sites, investigators, milestones
- Document completeness tracked against your SOP requirements
- EU data hosting — on secure servers in Germany
KPIs, overdue milestones, missing documents, and a live EU country map — the whole portfolio at a glance.
See it yourself — live demo with mock data:
Advanced Meta-Analysis Techniques
Pooling, heterogeneity, robustness, publication-bias, and certainty methods — 53 concepts, one per page, no fluff. What each method does, the maths in plain words, and what it cannot do. Free PDF, straight to your inbox.
Selected Engagements
Anonymized examples of recent client work — scope, deliverables, and timeline
Clinical Research SOP System
Complete clinical research SOP set — 20+ SOPs with forms and templates covering study planning, IB development, site selection, IIS governance, safety management and reporting, risk management, DSMB, data and documentation management, training, CIP, ICF, SAP, CIR, monitoring, CRO management, and regulatory submissions (FDA 510(k), EU, BfArM/EC).
Delivery: 3 months
Clinician Feedback Program
Designed the customer-feedback questionnaire for a flagship product, conducted face-to-face 1:1 clinician interviews at an EMEA advisory board summit, and delivered meeting minutes plus a full statistical analysis report — per-item Likert statistics with exact confidence intervals and a structured bias and limitations assessment.
Delivery: 1 week
Class III Pre-Market Study Package
End-to-end preparation of a Class III pre-market study: non-inferiority CIP against a historical control built from multiple systematic reviews, plus the Investigator's Brochure and the complete statistical design — sample size, endpoints, and SAP.
Delivery: Recurring
How an Engagement Works
Six steps, one point of contact throughout — from the first call to the final, audit-ready deliverable.
Discovery Call
A free 30-minute call to scope the device, timeline, and regulatory context — no commitment required.
Fixed-Scope Proposal
Deliverables, methodology, timeline, and price agreed upfront. No hourly surprises.
Hands-On Execution
The search, protocol, extraction, or writing — done personally, not delegated to a team.
Interim Checkpoints
Draft reviews built into the timeline, so you can course-correct before the final deliverable.
Delivery & QC
A finished, audit-ready deliverable — documented to withstand notified body or internal scrutiny.
Post-Delivery Support
Follow-up questions, notified body queries, and minor revisions covered after handoff.
Picks a time directly on the calendar — no back-and-forth emails.
From the notebook
Perspectives on clinical evidence, regulatory strategy, and statistical methods
Ready to discuss your project?
Send a brief description of the project — device type, regulatory context, or the workflow that needs fixing. Expect a response within 48 hours with an initial assessment and a proposed next step.