Ground it in the source
An answer should point back to the regulation, guideline or SOP it came from. That's why EmMA retrieves from EMA documents instead of relying on memory.
AI · Clinical trials · GCP
Putting AI to work in clinical trials, the GCP way.
I'm Rob Jones: TMF specialist, member of the TMF Reference Model Steering Committee, and 15+ years across CROs, sponsors and vendors. I write about using AI where quality, compliance and inspection readiness matter, and share what I build with it along the way.
15+ yrsin clinical research operations
30+countries using Pocket TMF
700+Pocket TMF downloads
iOS + Androidnative apps, built with AI
01 — Approach
How I use AI in a GCP world
AI is moving faster than our guidance. These are the rules I hold myself to while the rest catches up.
Keep a human accountable
AI drafts, sorts and suggests. A qualified person still reviews and decides, and the record shows who did what.
Validate it like any system
If it touches GCP data it gets the computerised-system treatment: intended use, testing, evidence. AI makes that faster, not optional.
Protect the data
Know where prompts and documents go. Pocket TMF collects no data at all, and that's the default I start from.
02 — Writing
All articles on LinkedInNotes on AI, the TMF and GCP
- The TMF Standard Model V1: Here's Where We Are (And Why This Time Next Year Actually Matters)TMF Standard Model · 4 min
- 1 Day, 5 Actual Uses for AI in a Real JobAI and Productivity · 9 min
- Stop Trying to Boil the Ocean: A Risk-Based Approach to AI in TMFAI and TMF · 6 min
- The TMF Standard Model V1: A Top Gun Moment for Clinical DocumentationTMF Standard Model · 6 min
- ICH E6(R3): The 10 Changes That Actually Impact Your TMF RecordsTMF and Regulations · 8 min
- Beyond the TMF: 5 Ways AI Made My Work Life Easier This MonthAI and Productivity · 7 min
- RAG and the TMF: When AI Finally Gets Its Homework RightAI and TMF · 6 min
- Standards: Stifling Creativity or Enabling Innovation?Standards · 4 min
- Why I'll Never Manually Create Test Data AgainComputerised System Validation · 4 min
- What Building My First App with AI Taught Me About the Future of Clinical ResearchAI and Innovation · 5 min
03 — Built with AI
What I've built
Everything here was built with AI as my pair programmer. Pocket TMF is a native app; EmMA is AI all the way down.
Pocket TMF
iOS · iPadOS · AndroidThe TMF and ISF Reference Models on your phone, searchable and fully offline, on iOS and Android.
30+countries
700+downloads
AI · RAGEmMA
A chatbot grounded in EMA regulations, guidelines and inspection findings. Ask it about the TMF.
Chat with EmMAMy setup
The hardware, software and AI tools I use to design and build everything here.
See the setup
Wallpapers
Two free collections for phone and desktop, made with AI.
Browse wallpapers04 — About
Started in the lab. Found my home in clinical operations.
Project management, regulatory affairs and clinical operations, now focused on the Trial Master File. If you're working on clinical trials, AI or healthcare innovation, I'd love to hear from you.
- Trial Master File (TMF)
- Clinical trial operations
- Regulations and guidelines
- Process automation
- Emerging technologies