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Menka AI – Monitoring 24/7

Menken Trials — AI-Powered Clinical Trial Compliance

Meet Menka AI.
Your always-on
compliance agent.

500+ real-time AI checks. Every document. Every study.
Zero inspection findings.
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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

24/7 always on

Menka AI's compliance status is monitored around the clock, every day

TRUSTED BY

Viljandi Hospital
regenold GmbH
North Estonia Medical Center
Lisata Therapeutics
Tartu University Hospital
Riga East Clinical University Hospital

The Menken Trials Platform

One compliance platform.
Many connected
solutions.

Every module is monitored by Menka AI — giving you a single, continuous audit trail across your entire clinical trial.

eTMF — Core Product

Trial Master File

500+ AI-powered checks, continuous document monitoring, CDISC-compliant structure. Where Menka AI is most active.

  • MENKA AI

eISF — Core Product

Investigator Site File

Automated logs, task routing, directly connected to the eTMF. Menka AI monitors both sides simultaneously.

  • MENKA AI

EDC

Electronic Data Capture

Launch studies in days. Drag-and-drop form builder, real-time edit checks, full compliance built in.

  • MENKA AI

Monitor

CRA Workspace

Visit planning, deadline tracking, AI-assisted report writing. Menka AI flags study risks in the background.

  • MENKA AI

Built to every

standard that matters.

GDPR

EU data protection

SOC 2 Type II

Security & confidentiality

ISO 27001

Information security

AICPA SOC

Service org controls

21 CFR Part 11

FDA electronic records

ICH-GCP

Good clinical practice

CDISC TMF RM

Reference Model v3.3.1

EMA GCP

European Medicines Agency

How Menka AI works

Your compliance colleague. Powered by AI.

Menka AI doesn't replace your team — she gives them back the time spent on document chasing, so they can focus on running the study.

Ask Menka AI Anything

Query your entire study in plain language.

"What's missing from artifact 4?" "Which sites have open signature requests?" Menka AI knows. Ask anything, get a direct answer — no digging through folders.

Menka AI's Continuous Quality Checks

500+ checks. Every document. In real time.

The moment a document is uploaded, Menka AI checks it. Missing signatures, expired certificates, version mismatches — she catches them before they become inspection findings.

Every check is logged. Every issue is tracked. Your audit trail builds automatically.

We believe in a human-in-the-loop model — you can always review Menka AI's checks to make sure nothing slips by.

Explore eTMF

Expiry and Deadline Tracking

CVs. Certificates. Signatures. All tracked automatically.

Menka AI monitors every expiry date — GCP certificates, investigator CVs, protocol versions, delegation logs. Reminders go out automatically. Nothing lapses quietly.

Explore eISF

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 — with a confidence score for review.

Explore eTMF

The week before your inspection.  Pick one.

Without Menka AI

Scrambling looks like this.

⚠️ Chasing missing signatures and outdated CVs
⚠️ Manually checking versions across multiple folders
⚠️ Realising training logs are out of date
⚠️ Hoping the TMF looks right — no time to check
⚠️ Expecting findings because everyone always does

With Menka AI

Confidence looks like this.

  • Every document checked and resolved, continuously, all study long.
  • AI-powered checks — nothing waits till the last minute.
  • A complete, up to date audit trail ready for any compliance check.
  • Full visibility of what auditors and inspectors will see — because Menka AI saw it first.

Your team focuses on the study. Menka AI has compliance covered.

500+

AI-powered compliance checks per study

60%

Less manual TMF QC — time your team gets back

<1 day

From configuration to a live study

24/7

Menka AI monitors your study around the clock

*Based on collected data from Menken Trials clients · Source: EMA GCP Inspectors Working Group Annual Reports 2023–2024

Trusted by

clinical teams.

"A very flexible and user-friendly database. You're not just buying a product — you're getting reliable technical support. We highly recommend without hesitation."

Dr Katrin Kaarna, MD

Head of Clinical Research Centre, Tartu University Hospital

"Menken eISF and eTMF are great solutions for every investigational 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

"This is one of the most wanted tools by CRAs. Finally!"

Kristina Scerbakovaite

CRA

Case Study

Supporting a First-Time Sponsor Through Inspection Readiness. Zero documenka-aition findings.

The collaboration with Menken Trials was described as a true partnership that provided clarity and confidence throughout the study and inspection process. Entering a first clinical trial and inspection can be overwhelming due to regulatory complexity, but the structured guidance and inspection-experienced support helped the team feel in control.

500+

AI-powered compliance checks per study

TMF + ISF

Deployed together

Built by people who've  
been there.

The Menken Trials team has worked in clinical research. We know where inspections go wrong — because we have been in the room when they do.

Menka AI isn't built on guesswork. She's built on firsthand knowledge of what regulators look for, what inspectors flag, and what trial teams need under pressure.

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