A South African-developed artificial intelligence platform designed to speed up the preparation and testing of clinical trial databases has placed second in the 2026 CDISC AI Innovation Challenge, highlighting its potential to reduce a time-consuming part of medical research.
The platform, called Leova, was developed by Johannesburg-based clinical data management company BioInformatiCo. It uses artificial intelligence to help research teams build databases, prepare data collection forms and test validation rules before a clinical trial begins.
Clinical trial databases are used to collect and manage information about participants during studies of medicines and vaccines. Preparing and checking these systems can take weeks of specialist work, with errors potentially leading to repeated work, data quality problems and delays.
BioInformatiCo said preparing and validating a clinical trial database can take between 10 and 20 weeks, depending on the study. Founder and chief executive Shirley Collie said errors discovered after a trial begins can require costly corrections and delay research.
Leova converts a study protocol into a structured digital model, from which it generates data collection forms, fields and checks designed to flag invalid entries. It then creates simulated participant data, including deliberately incorrect entries, to test whether the database detects problems before researchers begin collecting information from actual participants.
The company said the platform reduced the time required for database testing and validation in one study from five days of specialist work to one day. The result is a company-reported example rather than evidence that the same reduction will apply to all clinical trials.
Technology developed through African research operations
BioInformatiCo developed Leova to support its own clinical research work. The company manages data for studies ranging from first-in-human research to Phase 3 vaccine trials involving infectious diseases including HIV, tuberculosis, Ebola and COVID-19.
Collie said the platform was designed to help research teams reduce repetitive work while maintaining data quality and regulatory requirements.
“While automation cannot replace sustainable funding or specialist expertise, it can help research teams work more efficiently while maintaining the quality and reliability of clinical data,” she said.
The company combines the software with specialist clinical data management services and human oversight rather than offering the platform solely as a standalone product.
The development comes amid funding pressures affecting health programmes and medical research in South Africa following cuts to US funding. The supplied report identifies HIV programmes, clinical studies and research infrastructure among the areas affected, although it does not provide figures quantifying the impact.
Automation may reduce some operational costs, but it cannot replace funding for research staff, facilities, trial participants and other essential parts of clinical studies.
Global competition and expansion plans
Leova placed second among 19 submissions in Use Case 1 of the 2026 CDISC AI Innovation Challenge, which focused on using AI-generated synthetic data to automate software testing. Novartis and Amazon Web Services won the category with their Syn2Real framework.
The wider challenge attracted 50 submissions from 30 organisations and individual entrants across three categories. The competition is organised by the Clinical Data Interchange Standards Consortium, a global non-profit that develops standards for clinical research data.
Those standards support consistent collection, exchange and submission of clinical trial data, including information provided for regulatory review by the US Food and Drug Administration.
BioInformatiCo is expanding beyond sub-Saharan Africa, with a US site planned and discussions under way with potential sponsors in Europe and Australia, according to the company.
It also plans to open a seed funding round in the coming months to finance further development of Leova and support its commercial expansion.
