Leon Research has been running clinical trials for eighteen years. Spain, Italy, Portugal, a broad range of therapeutic areas, an ISO 9001 quality system they take seriously. They are, by any measure, good at this.
So when a team like that decides to add an AI compliance layer to how they run their documentation, it says something. Not about what was missing, but about where they think the work is going.
They have partnered with us to put Menka AI into their trial documentation.
The problem nobody enjoys talking about
Ask anyone who has sat through an inspection what they lost sleep over, and it is rarely the science. It is the Trial Master File. Is everything in it. Is it the current version. Did someone sign the thing they were supposed to sign four months ago.
The TMF is one of the key areas inspectors review, and one of the areas where findings commonly arise. Everyone knows this. The problem is that keeping it clean is slow, unglamorous work, and on a busy study it is always the thing you will get to later. Later has a way of arriving the week before an audit.
That is where Leon Research saw an opportunity to strengthen its existing approach: to have something checking the files as the work happens, alongside the quality processes already in place.
What Menka AI actually does
Menka AI is the compliance agent built into our platform. She reads documents. Not stores them, reads them.
The moment something is filed, she runs it against more than five hundred checks. A missing signature. A GCP certificate that quietly expired. A delegation log where someone is assigned a task their qualifications do not cover. The version that says “final” but is eighteen months old. The things a sharp reviewer catches on a good day, and misses on a Friday when three studies are on fire.
Two things matter about how she does it, and they are the reason a quality-first CRO like Leon Research was comfortable bringing her in.
First, she shows her work. When Menka AI flags something, she points to why: the exact protocol section, the SOP, the regulation it traces back to. You are never asked to trust a verdict you cannot check. Neither is an inspector.
Second, she does not overrule anyone. She does the first pass, at a speed and scale no person can match, and then a human decides what to do with it. The judgement stays with the team. What changes is that potential issues can be identified much earlier, as the work happens.
Why this partnership makes sense
Leon Research built its name on doing things properly. Honesty, flexibility, adapting to each client without cutting corners on GCP or their own quality system. That is a good fit for what we are trying to build, which is a way for teams to keep that standard every single day, without it eating their week.
They keep the systems and the way of working they already have. Menka AI sits on top and keeps watch.
They never leave you with a problem — they show up with a solution. Their AI-powered system gives us the speed and efficiency required and expected, but with real people behind it who genuinely understand our needs and are always there when we need them. We couldn’t ask for a better partner to have by our side.
Carla Nascimento, Head of Global Operations, Leon Research
Leon Research is exactly the kind of team we built this for. People who already do the work properly and just wanted a way to keep it that way, continuously, without adding to anyone’s load.
Anna-Liisa Parts, Co-founder and COO, Menken Trials
This is the start of the work, not the end of it. There is more coming, and we will talk about it as it happens.
About Leon Research
Leon Research is a CRO and pharmaceutical consulting company with eighteen years behind it, working directly in Spain, Italy and Portugal and across Europe through its partners. It covers the full arc of a study: design and planning, site selection, regulatory affairs, project management, clinical operations and monitoring, data management, medical devices and IVD, EU legal representation, vigilance, auditing and registration.
The team has worked across a broad range of therapeutic areas, with real depth in oncology, ophthalmology, cardiology, endocrinology, rare diseases, neurology and others. Its quality system is certified to ISO 9001:2015, its staff are trained in GCP and ISO 14155, and it is a member of AICROS and EUCROF and a recognised Innovative SME. Their line for it is simple: an expert on your path. Find them at leonresearch.com.
About Menken Trials
Menken Trials is a clinical compliance company built around Menka AI, an always-on agent that checks trial documentation as it is created rather than at the end. The platform covers eTMF, eISF and a monitoring workspace, and Menka AI runs more than five hundred checks across every document, log and milestone.
She explains every finding, keeps a person in the loop on every decision, and builds the audit trail as she goes. The platform follows the CDISC TMF Reference Model and the standards regulated research runs on, including GDPR, ISO 27001, SOC2 Type II, 21 CFR Part 11 and ICH-GCP. The point of all of it is one thing: documentation that is ready for inspection any day of the week, wherever it happens to live. More at menkentrials.com.
