Clinical data management organisation BioInformatiCo is preparing to open a seed funding round in the next two to three months to further develop and take its Leova AI platform beyond the operational environment in which it was built.
The Johannesburg-based company has developed an AI platform that already automates key parts of clinical trial database development and testing, with further development focused on expanding its capabilities and application.
The bottleneck: 10 to 20 weeks before a trial begins
Every clinical trial starts with a protocol defining what researchers will investigate, who can participate, what information must be collected and how the data will be evaluated. Translating that protocol into a functioning database is a specialised, labour-intensive process.
Data managers and programmers must build forms, configure validation rules and test the system against study requirements. Errors in the database compromise data quality, create costly rework and undermine confidence in results.
“Before the first participant can enrol, study teams may spend 10 to 20 weeks building and testing the database that will capture the study’s data, and for grant-funded African researchers investigating vaccines for infectious diseases such as HIV, TB and Ebola, that preparation comes at a price” states Shirley Collie, Founder and CEO of BioInformatiCo.
How Leova automates clinical trial database development
Leova brings the database build and testing process into a single workflow, from reading the study protocol and building the database to testing it before real participant data is involved.
“Leova brings these tasks into one workflow, from reading the study protocol and building the database to testing it before real participant data is involved. In one study,
“Leova reduced the testing and validation of a database from five days of specialist effort to one. By testing the system with synthetic participants, Leova can expose gaps before they become real-world data problems.” adds Collie.
Built from operational experience, not a product seeking a market
Leova emerged from BioInformatiCo’s experience building clinical trial databases, rather than from an attempt to create a standalone AI product and find a market for it afterwards.
“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.
“By automating repetitive work without compromising quality, we see an opportunity to change the economics of clinical data management and make high-quality research infrastructure more accessible.”
International recognition at the 2026 CDISC AI Innovation Challenge
The platform earned international recognition at the 2026 CDISC AI Innovation Challenge, which attracted 50 submissions from 30 organisations and individual entrants globally.
CDISC develops clinical data standards used in pharmaceutical research and regulatory submissions. Leova placed second out of 19 entries in Use Case 1, focused on AI-enabled synthetic data generation for automation testing.
The result placed South African-developed clinical research technology on a global stage, with Leova presented at the CDISC US Interchange in Denver in October 2026.
A different business model from software-as-a-service
BioInformatiCo’s business model differs from that of a conventional software-as-a-service provider. Instead of licensing the platform and expecting customers to operate it themselves, the company delivers verified databases alongside its clinical data management expertise.
The company bills against milestones rather than hours, aiming to reduce the manual work and scope changes that can make database builds expensive and unpredictable. For research teams navigating the realities of clinical research in Africa, the benefits include shorter preparation times, more predictable delivery and better use of limited budgets.
Why African research infrastructure matters
Collie believes Leova’s opportunity is particularly relevant in Africa, where stronger research infrastructure can help scientists generate, manage and evaluate high-quality evidence locally while contributing to global medical knowledge.
“African researchers need to be able to own, control and evaluate their own data. Strong clinical data management systems are essential to making that possible, and to ensuring that high-quality research generated on the continent can contribute meaningfully to global medical knowledge,” says Professor Glenda Gray, Director of the Infectious Disease and Oncology Research Institute (IDORI) at Wits, past President and CEO of the South African Medical Research Council, and Principal Investigator of the BRILLIANT Consortium.
For Collie, this is precisely the gap Leova is designed to help address.
Seed funding round planned within two to three months
BioInformatiCo plans to open a seed funding round in the next two to three months to further develop and take Leova beyond the operational environment in which it was developed.
The investment case is built around a clear industry problem, technology developed within a working clinical data management organisation and the potential to expand into a scalable service for African researchers and international sponsors.
For researchers, the promise is more efficient use of constrained budgets. For sponsors, it is a faster route to clinical trial readiness. For BioInformatiCo, it is an opportunity to turn operational expertise into a differentiated, scalable business.
The company is inviting interested investors and funders to make contact ahead of the planned seed round.
