Johannesburg-based BioInformatiCo — a South African-developed AI platform that helps researchers prepare clinical trial databases more quickly — was a runner-up in the 2026 CDISC AI Innovation Challenge.
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It placed second among 19 entries in use case one, which focused on using AI-generated synthetic data to automate software testing, highlighting the potential for African innovation on an international stage.
Solving a key bottleneck
The platform, called Leova, automates parts of building and testing the digital databases used to collect information during trials of new medicines and vaccines.
By reducing the time and manual effort required to prepare these systems, the platform aims to help research teams identify database errors and protocol inconsistencies earlier, while freeing up resources for the research itself.
For Shirley Collie, founder and CEO of BioInformatiCo, the global recognition is an important milestone and a sign that African-developed technology can contribute to clinical research globally.
“Placing second in the CDISC AI Innovation Challenge is an important endorsement of what we have built,” says Collie.
“It shows that technology developed in Africa can help tackle challenges in clinical research worldwide, while supporting the continent’s ability to generate evidence that reflects the health needs of its own populations,” Collie adds.
Practical demands
BioInformatiCo developed Leova within its existing clinical research operations, drawing on the practical demands of building reliable clinical trial databases.
The company currently supports first-in-human to phase three vaccine research for infectious diseases, including HIV, TB, Ebola and Covid-19.
CDISC’s recognition also comes as US funding cuts have disrupted health programmes and medical research in South Africa, adding pressure to an already stretched research ecosystem.
HIV programmes, clinical studies, and research infrastructure have been especially affected, while universities and research organisations face funding shortfalls and uncertainty over grants.
Real operational need
In this environment, automating time-consuming manual work, such as building and testing a study database, can cut both hours and costs and help limited resources go further.
“Before a new medicine or vaccine can reach patients, clinical trials must establish whether it is safe and effective,” remarks Collie.
“But before the first participant can enrol, researchers need reliable systems to collect and manage the study data.
“Building and validating these databases can take 10 to 20 weeks of specialist work, with each system tailored to the trial’s specific research protocol.
“Errors at this stage can compromise data quality, create costly rework and delay the trial,” adds Collie.
Built to support clinical data management capacity on the African continent, the platform uses a study protocol to draft data collection forms and validation rules, builds the database and then tests it with simulated participants designed to break those rules.
This allows research teams to identify weaknesses before using the system in a live trial.
“Leova was born out of a real operational need. We understand the pressure clinical research teams face to deliver reliable data, meet demanding standards and make every Rand count.
“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,” adds Collie.
The next phase
In one study, Leova reduced database testing and validation from five days of specialist effort to one.
This shows how the platform reduces validation time and cost and gets studies ready sooner, while maintaining the traceability and quality controls required in clinical research.
BioInformatiCo supports clinical trials across sub-Saharan Africa and is expanding internationally, with a US site launching soon and sponsor discussions under way in Europe and Australia.
The company also plans to open a seed funding round in the coming months to support Leova’s next phase of development and commercial growth.
“This is an exciting time for South African innovation. We’ve built Leova to solve a real challenge in clinical research, drawing on our experience on the ground in Africa.
“Now, we have an opportunity to take that expertise and technology to the world, helping research teams work more efficiently while strengthening Africa’s contribution to global health research. We’re looking forward to what comes next,” concludes Collie.
