SOUTHBOROUGH, Mass. — Veristat has launched InStat, an AI-enabled biostatistics platform designed to reduce clinical trial data readout time from weeks to days while maintaining validated statistical processes.
The Southborough-based clinical research organization and consultancy said InStat is a zero-code, fully automated biostatistics platform that produces submission-ready tables, listings and figures, known as TLFs. Veristat said the platform can deliver those outputs in five days or less, compared with the four to six weeks sponsors typically wait after database lock.
Veristat said InStat uses AI agents to translate biostatisticians’ descriptions into precise specifications. Those specifications then drive a library of validated statistical engines, rather than relying on large language models to generate analysis code.
The company said the platform is intended to speed clinical trial readouts without adding regulatory risk. Outputs are backed by validated statistical engines and reviewed by expert biostatisticians.
Veristat plans to begin using InStat to deliver biostatistics services in June. Clene Nanomedicine is the first clinical trial sponsor whose work was delivered using the platform. Veristat said the work included NfL biomarker analyses supporting Clene’s planned 2026 New Drug Application for CNM-Au8.
“Following recent FDA interactions, we are advancing our NDA submission for CNM-Au8 with NfL biomarker concordance evidence as a core component of the accelerated approval pathway argument under Subpart H,” said Michael Hotchkin, Chief Development Officer at Clene Nanomedicine. “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. Clene is continuing to work with Veristat on the NDA submission planned for later this year.”
Veristat said delays after trial completion can slow regulatory submissions and potential approvals, creating significant financial costs for sponsors while patients continue waiting for new treatment options.
The company said InStat also includes a secure online portal that allows sponsors and Veristat teams to review and finalize biostatistical readouts collaboratively in real time. The platform is system-agnostic, allowing sponsors to use their preferred electronic data capture system and maintain their own formatting.
“Veristat is re-engineering how complex biostatistical work gets done in clinical research,” said Kyle McBride, Veristat Vice President, AI & Innovation. “InStat is a modern solution built off a foundation of two decades of proven biostatistical analysis. We intentionally put AI where it adds speed, not where it adds risk: assisting biostatisticians in translating analytical intent into precise specifications. Once that’s right, everything downstream is trustworthy.”
