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.

Why we built it



What you can ask us for



What CDISC made of it

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.

Study build, accelerated, by a CRO that owns the technology doing the accelerating

PROTOCOL — DEFINITION — BUILD — VERIFY —

• 
  LIVE

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

Study Build

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

• 
  A structured study definition drawn from your protocol
• 
  CDASH-aligned eCRF, display logic and edit-check design
• 
  Build configured in your EDC
• 
  Verification against the live build
• 
  Test evidence
• 
  A named data project manager for the life of the study build

Best for

Teams who need the database right and need it quickly, and have the rest of the study covered.

How the study build works

Full service

Full data management services

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

• 
  Everything in Study Build
• 
  Authoring and maintaining the Data Management Plan and Data Validation Plan
• 
  Authoring eCRF completion guidelines
• 
  Clinical database user management
• 
  Export/ETL pipelines and data transfer specifications
• 
  Medical coding (MedDRA/WHODrug)
• 
  Clinical database change control
• 
  Local laboratory normal range management
• 
  Central monitoring and key risk indicator support under RBQM
• 
  Interim dataset preparation for DSMB or PSRT review
• 
  External vendor data reconciliation
• 
  Ongoing data management and query handling
• 
  Operational reporting on enrolment, retention and protocol adherence

Best for

Sponsors and investigators who want one accountable partner from first participant to final submission.

See everything we offer

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.

• 
  Your protocol, as you already have it
• 
  Access to your EDC
• 
  Input on the questions the protocol leaves open

What you get back

A build you own, with the evidence behind it.

• 
  A configured, tested study database in your EDC
• 
  Test evidence: what was checked, what fired, what didn’t
• 
  A named build owner for the life of the study build

CDISC RECOGNISED

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