Boston — Beaconcure has launched Verify Intelligence, an artificial intelligence-based review tool designed to automate validation of tables, listings and figures used in clinical trials.
The company said the technology is already in production at a top 10 biopharmaceutical company and is intended to provide an independent check on statistical programming used in regulatory submissions.
Clinical trial submissions can include hundreds or thousands of tables, listings and figures, commonly known as TLFs. Sponsors and contract research organizations typically validate those outputs using double programming and manual review.
Beaconcure said Verify Intelligence takes a different approach by reading study specifications and source data, generating its own version of each output and comparing it with the version produced by the statistical programming team.
When differences are identified, the system highlights them and traces them back to the underlying source data. The AI flags discrepancies, while statisticians and programmers retain responsibility for reviewing and resolving them.
“Double programming has been the industry’s safety net for decades, but two people reading the same specification can make the same mistake,” said Seth Houston, Chief Executive Officer of Beaconcure. “Verify Intelligence gives biometrics teams a second reviewer that approaches the work from a different direction.”
Beaconcure said the system was developed with input from two major biopharmaceutical companies, whose biometrics teams helped define requirements for using AI-based review in a regulated environment.
One of those companies has moved Verify Intelligence into production, while the second plans to deploy the technology in 2027.
“Going into production with a Top 10 biopharma company shows the approach holds up in a real submission environment,” Houston said. “The pilots starting next year will take it across more studies and therapeutic areas, and we expect what we learn there to shape future releases.”
Beaconcure said the launch comes as regulators establish clearer expectations around the use of artificial intelligence in drug development, including requirements related to human oversight, data governance and documentation.
The company said Verify Intelligence was designed to support expert review while maintaining a record of how each result was generated.
For sponsors that outsource statistical programming, the technology can also be used to independently review outputs produced by contract research organizations.
Verify Intelligence is part of Beaconcure’s broader Verify platform. Other modules include Verify Translate for preparing and harmonizing source data, Verify Validation for centralized TLF review and automated quality checks, and Verify Control for study oversight.
