HOW WE DELIVER
We accelerate study
builds with technology
we built ourselves
We manage clinical data and configure study builds — and we have built AI-powered software that gets those databases live faster. This technology came out of executing our own study builds, cycle after cycle. We felt the pain, so we built the fix.
You get the acceleration, with no software to license, learn or log into.
BY BIOINFORMATICO
STUDY-BUILD TECHNOLOGY
Leova is our own proprietary AI-powered tooling that takes your protocol and turns it into a built and tested study database.
This tooling enables us to compress weeks of study build and testing time, to provide the most efficient and affordable solutions to our sponsors.
PROTOCOL — DEFINITION — BUILD — VERIFY —
SCROLL TO EXPLORE
WHY WE BUILT IT
We built it for studies that cannot wait
This technology was built to accelerate the COVID-19, HIV, TB and Ebola vaccine trials we support across sub-Saharan Africa. It exists because we needed rapid database go-live ourselves, under deadlines we did not set.
Grant-funded and investigator-led research is underserved by data technology providers because its budgets are small. We have chosen to build for this segment deliberately. We believe that these studies are where better technology can do the most good, making every grant go further.
Delivering regulatory-grade data systems at a price research budgets can bear forced us to engineer efficiency into every step of how we work.
The same technology and methods now serve our biotech clients, who get the benefit of that discipline at commercial scale.
TWO WAYS TO WORK WITH US
Take the build, or take the whole study
Both start with your protocol. The difference is how much of the study you want us to carry after the database is live.
Scoped engagement
You already have a data management team, or a sponsor who provides one. We build and verify the study database, hand it over with the evidence, and step back.
What’s Included
Best for
Teams who need the database right and need it quickly, and have the rest of the study covered.
Full service
Everything in Study Build, plus the plans, the coding, the reconciliations and the oversight that carry a trial from first participant in through to database lock.
What’s Included
Best for
Sponsors and investigators who want one accountable partner from first participant to final submission.
STUDY BUILD
How we use our technology to build your study database
You send a protocol. We return a verified study database in the EDC your trial will run on, the configuration files behind it, and the test evidence showing what was checked and what it caught.
Our people run every step. The technology is what makes them fast.
01
Protocol In
HUMAN-LED
Your protocol, in whatever form you already have it. No template to complete first, no intermediate configuration step before work can start. A data manager does the reading, asks the clinical questions, and gets the source ready for the pipeline.
02
A protocol the system can read
SYSTEM, HUMAN-DRIVEN
We convert the protocol into two working artefacts: the full protocol text indexed in plain text, and a scaffold that defines the study in machine-readable form. Every step that follows references those artefacts. The PDF stops being the source, so nothing is lost between reading it and building from it.
03
Forms and checks that cite their source
SYSTEM, HUMAN-DRIVEN
CDASH-aligned eCRFs, edit checks and form display logic, drafted against the scaffold to conventions tuned over previous builds. Every field, rule and display condition has to cite the part of the protocol it comes from and why it exists. Lineage is a requirement of the scaffold, not a document written afterwards.
04
Clinician approval
CLINICAN
A clinician with investigator experience reviews the forms and rules, and edits them. Nothing moves to build until that review is closed.
05
Built for your EDC, not a demo
DATABASE PROGRAMMERS
Our database programmers generate configuration files targeted at the EDC your trial will actually run on, import them, and check that every form, rule and code list has landed as specified. You are not paying for hours of manual building, and you are not signing off a demonstration environment that behaves differently under load.
06
Verification by humans and machines
SYSTEM, DATABASE PROGRAMMERS
Our team runs UAT against the live build, driving automated test participants — including deliberately problematic ones — through every eCRF in scope. We record what fired correctly, what fired when it shouldn’t have, and what should have fired and didn’t. A database programmer reviews every result, and updates the build accordingly.
07
Evidence pack and sign-off
YOU
You receive the UAT outputs, the test evidence and the configuration files, with a named build owner who stays with the study from intake to go-live rather than handing it down a queue. Sign-off is yours, on evidence, not on assurance.
What we need from you
No template to complete first. Any format works, because we do the conversion.
What you get back
A build you own, with the evidence behind it.
STUDY BUILD
How we use our technology to build your study database
You send a protocol. We return a verified study database in the EDC your trial will run on, the configuration files behind it, and the test evidence showing what was checked and what it caught.
Our people run every step. The technology is what makes them fast.
01
Protocol In
Your protocol, in whatever form you already have it. No template to complete first, no intermediate configuration step before work can start. A data manager does the reading, asks the clinical questions, and gets the source ready for the pipeline.
HUMAN-LED
02
A protocol the system can read
We convert the protocol into two working artefacts: the full protocol text indexed in plain text, and a scaffold that defines the study in machine-readable form. Every step that follows references those artefacts. The PDF stops being the source, so nothing is lost between reading it and building from it.
SYSTEM, HUMAN-DRIVEN
03
Forms and checks that cite their source
CDASH-aligned eCRFs, edit checks and form display logic, drafted against the scaffold to conventions tuned over previous builds. Every field, rule and display condition has to cite the part of the protocol it comes from and why it exists. Lineage is a requirement of the scaffold, not a document written afterwards.
SYSTEM, HUMAN-DRIVEN
04
Clinician approval
A clinician with investigator experience reviews the forms and rules, and edits them. Nothing moves to build until that review is closed.
CLINICIAN
05
Built for your EDC, not a demo
Our database programmers generate configuration files targeted at the EDC your trial will actually run on, import them, and check that every form, rule and code list has landed as specified. You are not paying for hours of manual building, and you are not signing off a demonstration environment that behaves differently under load.
DATABASE PROGRAMMERS
06
Verification by humans and machines
Our team runs UAT against the live build, driving automated test participants — including deliberately problematic ones — through every eCRF in scope. We record what fired correctly, what fired when it shouldn’t have, and what should have fired and didn’t. A database programmer reviews every result, and updates the build accordingly.
SYSTEM, DATABASE PROGRAMMERS
07
Evidence pack and sign-off
You receive the UAT outputs, the test evidence and the configuration files, with a named build owner who stays with the study from intake to go-live rather than handing it down a queue. Sign-off is yours, on evidence, not on assurance.
YOU
What we need from you
No template to complete first. Any format works, because we do the conversion.
What you get back
A build you own, with the evidence behind it.
CDISC RUNNER-UP
Judged by CDISC,
awarded runner-up
Every CRO says it is technology-enabled. Very few can point to an innovation judged by the standards body that FDA and PMDA defer to. A vision of Leova was entered into the 2026 CDISC AI Innovation Challenge and placed second of 19 submissions.
2
nd of 19
2026 CDISC AI Innovation Challenge
Use Case #1
USE CASE
AI-enabled synthetic data generation for automation testing
INVITED DEMONSTRATION
CDISC US Interchange, Denver — 5 October 2026, Session 3, Track C
WHY IT MATTERS
CDISC is the standards body behind CDASH, SDTM and ADaM — the placing is an assessment of the engineering by the people who wrote the rules it is built against.
A NOTE ON WHAT LEOVA IS
Leova is not a product you buy — it is how we build your study
It is tooling we run on your behalf, and there is nothing for your team to administer. What you receive is a verified study database and a data management team.
NOTHING TO LICENSE
NOTHING TO LEARN
NOTHING TO LOG INTO
GET A QUOTE
Send us a protocol, and we’ll tell you what the build costs