Operations & Workflow Optimization
Your evidence is only as good as the workflows that produce it. I bring structure to how clinical work is run — studies, documentation, and standard operating procedures — so the same rigor that makes your evidence defensible makes your operations efficient and audit-ready.
Typical Deliverables
The Problem
Clinical work outgrows the tools that hold it. Investigator-Initiated Studies are tracked across spreadsheets and shared folders; study documentation is scattered and hard to keep audit-ready; SOPs drift from how the team actually works, or were written once and never revisited. Manual, repetitive steps slow everything down and quietly create compliance risk. None of this is a science problem — it is a workflow problem, and it rarely gets solved by adding more documents.
My Approach
The same structural thinking that aligns clinical claims to evidence aligns internal operations to strategy. I start from how your team actually works, map where studies, documents, and decisions get stuck, and design lightweight systems that fit your real processes — not idealized ones.
Because the person who understands the clinical science, the regulatory framework, and the statistics is the same person fixing the workflow, the result stays consistent with your evidence and your obligations. One expert, no handoffs.
Service Catalog
Investigator-Initiated Study (IIS) Management
Structured governance of the full IIS lifecycle — intake, review, contracting, milestones and payments, document checklists, communications, and close-out — instead of email threads and spreadsheets. I can set up the workflow around your own SOPs, or deploy a purpose-built management tool tailored to your procedures.
See it in action: a live, interactive IIS management demo (synthetic data) is available now. Explore the IIS demo →
Process Automation
Identify the repetitive, manual steps in your clinical and regulatory workflows — tracking, reminders, status reporting, document assembly, data extraction — and replace them with reliable, auditable automation. The goal is fewer handoffs and fewer transcription errors, not technology for its own sake.
Medical Writing & Study Documentation
Clear, regulation-aligned study documentation — clinical investigation plans (CIP), investigator brochures (IB), statistical analysis plans (SAP), reports, and the supporting forms — written by the same scientist who understands the underlying data. Includes reusable, audit-ready templates so future documents stay consistent and faster to produce.
SOP Audits & Revisions
A structured review of your existing standard operating procedures against ISO 14155, EU-MDR, and ICH E6(R2)/GCP — and against how your team actually works. I identify gaps, contradictions, and shelf documents, then revise them into practical, usable SOPs with clear responsibilities, process flows, and templates that people will actually follow.
Standards & Frameworks
Operations and documentation work is delivered in line with:
- ISO 14155 — Clinical investigation of medical devices
- EU Medical Device Regulation (EU) 2017/745 — Chapter VI
- ICH E6(R2) — Good Clinical Practice
- GAMP 5 — Validation of computerised systems (for any deployed tool)
- 21 CFR Part 11 — Electronic records & signatures (where applicable)
Want to streamline how your studies, documents, and SOPs are run?
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