I spent years monitoring and managing clinical trials across Europe — at some of the largest pharmaceutical and biotech companies on the continent. I have sat in rooms during inspections. I have watched findings get recorded that, had anyone been looking continuously, would have been caught weeks or months earlier.
The same problems appeared again and again. A delegation log that referenced a task the investigator had not been trained for. A GCP certificate that expired mid-study without a renewal reminder in place. A protocol amendment that referenced version 4.1 — but version 4.1 had never been filed in the TMF.
None of these are the result of careless teams. They are the result of a system that checks periodically instead of continuously.
When Jürgen and I started building Menken Trials, fixing this was the goal. Today, we are introducing the result.
Who is Menka AI?
Menka AI is an always-on compliance agent built directly into the Menken Trials platform. She is not a report that runs weekly. She is not a checklist your CRA completes at monitoring. She is a system that is actively checking every document in your study, every moment your study is running.
The moment a document enters your eTMF or eISF, Menka AI begins working.
She is the system I always wished existed when I was in the field.
What Menka AI actually does
When a document is uploaded, Menka AI runs over 500 compliance checks immediately. Not on a schedule. Not at the end of a QC cycle. Immediately.
Those checks cover:
Document integrity. Correct document type, version alignment, proper classification against the CDISC TMF Reference Model v3.3.1. If a document does not belong where it has been filed, Menka AI flags it.
Signature and delegation verification. If a delegated task appears in the delegation log and the person it is delegated to has no corresponding training record, Menka AI flags it. This is one of the most common GCP inspection findings — and one of the easiest to prevent if someone is always watching.
Expiry and deadline tracking. GCP certificates. Investigator CVs. Financial disclosures. Protocol version timelines. Menka AI monitors every expiry date across the study and sends reminders at 60 days and 30 days. Automatically. Without anyone setting up a manual tracker.
Cross-document consistency. If a document references a protocol version that does not exist in the TMF, Menka AI catches it. If a consent form version does not match the active version on file, Menka AI flags it. These are the discrepancies that sit undetected for months and surface during inspections.
Plain-language answers to plain-language questions. You can ask Menka AI: “What is missing from Artifact 4?” or “Are we inspection-ready right now?” and receive a specific answer. Not a dashboard that requires interpretation. A direct answer.
What Menka AI is not
Menka AI does not make decisions. She does not close findings, archive documents, or override the judgment of your team. She watches, flags, and routes.
The expertise stays with your people. The accountability stays with your people. Menka AI removes the work that should never have been manual in the first place — and gives your team back the time they were spending on document chasing.
In an industry where AI near patient safety rightly makes people cautious, we built a system that keeps humans fully in control. We call it human-in-the-loop by design, not as a disclaimer.
The result: zero inspection findings
Across every Menken Trials client. Every study. Ever.
That is not a marketing claim. It is the standard Menka AI is built to maintain — and the one we hold ourselves to with every client we onboard.
When a Menken Trials client goes into an inspection, they go in knowing that every document has been checked, every expiry has been tracked, every cross-reference has been verified. Not because they worked through a checklist the week before. Because Menka AI was working the entire time.
Why we built her now
The technology to do this has existed for some time. What has been missing is a team that understood clinical research well enough to build it correctly — not approximated from general AI training data, but validated against real regulatory requirements, real inspection findings, and real study data.
Our team has worked in clinical research. We have monitored studies. We have been in the room when inspections go wrong. We built Menka AI because we knew exactly what she needed to catch — because we had seen what happened when nobody was catching it.
See Menka AI for yourself
Jürgen and I recorded a short video introducing Menka AI: who she is, why she exists, and what she does in practice. It is under two minutes.
If you would like to see Menka AI working on a real study scenario relevant to what your team is running, we offer 15-minute sessions — no pitch, no demo theatre, just the platform doing its job on a problem that matters to you.
Menka AI is an AI agent. The name and avatar do not represent a real individual.
