InovaMine ingests interventional study and real-world data, runs the statistical analysis plan against it, and returns tables, listings and figures with every number traceable to the patient of origin.

LONDON, Nov. 5, 2026 /PRNewswire/ — Inovia Bio, the TechBio company that builds AI platforms for drug development, today announced the launch of InovaMine, an end-to-end biostatistics and data pipeline platform. InovaMine takes a dataset and a statistical analysis plan (SAP) and returns the tables, listings and figures (TLFs) the SAP specifies, to submission standard. It works with interventional trial data (SDTM, ADaM, EDC exports) and with longitudinal real-world data from hospital, claims, EHR and registry sources. Each source is validated and harmonised into one of two common data models, one for interventional studies and one for real-world data, so the analysis is written once, tested continuously, and produces the same results whichever dataset it is run on. Click on the image to see how InovaMine works:

Once a study’s data is locked, producing the first set of tables takes weeks, because the programming and validation are rebuilt for every study. Every follow-up question, whether a new subgroup or a sensitivity analysis, costs another cycle of the same work. As a result, teams have to prioritise which questions they can afford to ask, and valuable insights go unexplored.

InovaMine removes the rebuild. The ingestion pipelines, data quality tests and analysis code already exist, so a new study or a new question is configuration rather than a programming project. On a data source already in the platform, the SAP runs in hours and reviewed tables are delivered within five working days. A new data source is onboarded in one to two weeks. For emerging biotechs, that means an evidence programme beyond the primary study becomes affordable. For pharmaceutical sponsors, it means subgroup and sensitivity analyses arrive in days rather than the following quarter.

“Give InovaMine a dataset and the statistical analysis plan (SAP), and it gives you back the tables, tested and traceable to every subject. That turns weeks of programming into days of review,” said Antonio Nicolae, Co-Founder and Chief Technology Officer of Inovia Bio. “It means anyone on the team can explore a new cohort without queuing for the biostats team. We built it to make good statisticians faster and the rest of the company more curious.”

InovaMine is built for regulatory reproducibility. Every number in every table can be traced back to the SAP line that specified it, the derivation that produced it, the cohort rule that admitted each patient, and the source record. Thousands of automated tests run on every data load, every transformation and every output, giving sponsors a reproducible record of how each result was calculated and giving reviewers a clear line from table to source.

“Regulators do not ask whether your analysis was clever. They ask whether it followed the SAP and whether you can show it,” said Imi Faghmous, Co-Founder and Chief Scientific Officer of Inovia Bio. “InovaMine gives sponsors that by default, on RWD and interventional study data alike. Every subject in every cohort comes with the reason they are there, so reviewers review rather than take it on faith. And it frees scientists to do science: explore cohorts, test hypotheses, change their minds. For a small biotech that is an evidence package they could never have produced by hand.”

Human oversight remains central. Every table and figure is reviewed and signed off by a qualified statistician or epidemiologist before it is released. InovaMine has powered Inovia Bio’s regulatory real-world evidence work for two years and is available today to biotech and pharmaceutical sponsors worldwide.

About Inovia Bio:
Inovia Bio helps biotech and pharmaceutical organizations move therapies forward faster. Its AI platforms turn months of work into days, so experts spend their time on decisions, not drafts. Learn more at Inovia.Bio.

Media Contact:
Jeff Rusack
Sōvyn
inoviabio@sovyn.com

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SOURCE Inovia Bio