TMF compliance should never need a Menka AI fire drill.
Menka AI runs 500+ continuous AI checks across every essential document in your eTMF — so inspection readiness isn't something you prepare for. It's something you already have, while your study is running.
Essential document issues are the #1 source of GCP inspection findings.
Source: EMA GCP Inspectors Working Group Annual Reports 2023–2024
Missing documents, late reviews, version mismatches. Most are avoidable — but only if someone is watching continuously while your study is running. Menka AI does exactly that, every minute of every day.
Menka AI's Continuous Quality Checks
500+ checks. Every document. In real time.
Menka AI checks every document for missing signatures, version errors, and expired certificates — the moment it's uploaded and continuously throughout your study.
AI Metadata Extraction
Upload a document. Menka AI does the filing.
Menka AI's AI models automatically extract and file key metadata — document date, version, protocol number, person name — with a confidence score for review.
Less manual typing, fewer errors, faster document management. Always CDISC TMF Reference Model v3.3.1 compliant.
CDISC-Compliant Structure
Built with standards. Flexible for how you work.
The structure follows CDISC TMF Reference Model v3.3.1 so inspectors can navigate it comfortably. Fully configurable — bring your own templates, log formats, and workflows.
Inspectors have praised the navigation for its clarity. That matters when someone is reviewing your files under pressure.
Role-Based Visibility
Everyone sees what they need, when they need it.
Visibility is managed through the TMF matrix — sponsors, CROs, CRAs, auditors, and inspectors each see exactly what they are permitted to see. Confidential site documents stay at site level. Internal study documents are not visible to sites.
Menka AI — built into eTMF
Ask Menka AI anything about your TMF.
Menka AI doesn't just monitor your eTMF — she understands it. Ask in plain language. Get a direct answer.
No digging through folders. No manual status reports. Just ask.
"What's missing from Zone 4?"
Menka AI gives you a list, with direct links and due dates.
"Are we inspection-ready?"
Menka AI tells you exactly where you stand — and what needs fixing.
"Which CVs are expiring this month?"
Menka AI tracks every expiry and sends reminders automatically.
We believe in a human-in-the-loop model — you can always review Menka AI's checks to make sure nothing slips by.
Our commitment
We guarantee compliance. Full stop.
Every client using Menken Trials has zero inspection findings related
to our platform. Menka AI makes that possible — catching everything,
leaving nothing to find.
0 findings
Inspection findings related to our platform — across every client, every study, ever
500+ AI checks
Real-time compliance checks running on every document, log, and milestone
60% less
Manual TMF QC work — time your team gets back to focus on the study*
Menken eISF and eTMF are great solutions for every investigational team and study team — reducing the administrative burden on site level and improving overall site quality.
Dr Katrin Kaarna, MD
Head of Clinical Research Centre, Tartu University Hospital
Frequently asked questions.
Can we use this for a CRO-wide licence?
Yes. Volume and portfolio pricing is available for TA-specific and multi-sponsor use. Contact us to discuss your setup.
Can you white-label the platform for our CRO?
Yes. We offer a simple fee-based adaptation for CRO logo and colour themes.
We have existing templates. Do we have to change them?
(BYOT) Bring Your Own Templates — we easily configure them into the platform. Nothing changes about how your team works. Your team can focus on their work, with Menka AI providing continuous digital control and inspection readiness
What about long-term archiving?
We support the 25-year TMF storage requirement on our compliant cloud, with GDPR, SOC 2 Type II, and ISO 27001 certification.
Can Menka AI work alongside our existing systems?
Menka AI is built into the Menken Trials platform. Integration with external systems is a possibility — talk to us about your setup.
How long does it take to get started?
From agreed configuration to a live study is typically less than one day. Team training takes under one hour on average.
💬 Don't see your question here?
Contact us directly and we'll answer it. Every question helps us improve this page
Let Menka AI show you what she sees.
Book a short call. We'll walk through a real study and show you how Menka AI works — and what she'd find in your current TMF.
Menka AI is an AI agent. The name and avatar do not represent a real individual.
