Veristat has launched an AI-enabled biostatistics platform designed to reduce the time needed to generate clinical trial data outputs used in regulatory submissions.

The new platform, InStat, automates the production of submission-ready tables, listings and figures, which are typically prepared after database lock and used to support regulatory filings such as new drug applications.

According to Veristat, the platform can reduce turnaround times from the industry standard of four to six weeks to five days or less, combining automated statistical processing with expert biostatistician review.

The company said the system uses validated statistical engines rather than large language model-generated analysis code, aiming to improve efficiency while avoiding regulatory risks associated with AI-generated outputs.

Veristat plans to begin delivering biostatistics services using the platform in June.

Clene Nanomedicine is the first clinical trial sponsor to use InStat, with biomarker analyses generated to support its planned 2026 new drug application for CNM-Au8.

Michael Hotchkin, chief development officer at Clene Nanomedicine, said: “Veristat produced the supporting NfL biomarker analyses with InStat, delivering tables in days rather than the weeks that similar analyses typically demand, and our biostatistics team verified the outputs through detailed review.”

Biostatistical analysis remains a critical but often time-intensive stage in clinical development, requiring the generation of standardised outputs used to interpret trial results and support regulatory submissions.

Veristat said InStat also enables sponsors to review data outputs through a secure online portal, allowing more direct collaboration during the finalisation process.

Kyle McBride, vice president of AI and innovation at Veristat, said: “We intentionally put AI where it adds speed, not where it adds risk: assisting biostatisticians in translating analytical intent into precise specifications.”

The launch reflects growing interest in targeted artificial intelligence applications across clinical development, particularly tools designed to streamline operational bottlenecks without compromising regulatory compliance.