Veristat Launches AI Biostatistics Platform, Cutting Clinical Trial Data Readout Time from 5 Weeks to 5 Days* Without Regulatory Risks

InStat™ delivers submission-ready tables, lists and figures (TLF) on validated statistical engines, with Clene Nanomedicine as its first customer

SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat^™, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced the launch of InStat^™ by Veristat. InStat is the clinical research industry’s first zero-code, fully automated biostatistics solution, reducing manual effort to speed time to approval with every output backed by validated statistical engines and expert biostatistician review. It delivers submission-ready tables, listings, and figures (TLF) in five days or less^*, rather than the four to six weeks sponsors typically wait after database lock, while maintaining the highest quality data.

Veristat will begin using InStat to deliver biostatistics services in June. Clene Nanomedicine is the first clinical trial sponsor whose work was delivered using InStat, with NfL biomarker analyses supporting their planned 2026 New Drug Application (NDA).

"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."

At trial end, sponsors traditionally wait weeks for biostatisticians to manually analyze volumes of study data. Such delays to approval can cost sponsors $500,000 or more a day in potential, unrealized sales while patients remain burdened by their disease. Veristat’s InStat platform dramatically accelerates time to approval and helps sponsors realize market gains earlier with AI agents that turn biostatisticians descriptions into precise specifications. Those specifications drive a library of validated statistical engines that perform every analytical step – enabling the speed of automation without the risk or regulatory exposure of LLM-generated analysis code.

Equally important, InStat enables transparent, collaborative readout reviews for better quality data, faster. Rather than sponsor and CRO commenting back and forth on drafts over weeks, sponsors can log into a secure online portal where they can work directly with Veristat in real time to finalize biostatistical readouts. And because InStat is system-agnostic, sponsors can use their preferred electronic data capture system and maintain their unique 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.”

Request an InStat demo on a completed study here. Veristat is also hosting a limited-invite event featuring Ken Getz, Executive Director and Research Professor at the Tufts Center for the Study of Drug Development, on May 18, 2026 in Boston.

Request an invitation at https://www.veristat.com/instat-insiders-look

*Time reduction varies depending on type of trial, number of sites, and number of participants.

About Veristat

Veristat is a full-service CRO and consultancy that helps life sciences companies bring novel therapies to market fast. With 30 years of experience and support in more than 100 regulatory approvals and deep expertise in rare disease, neurological disease, oncology, and advanced therapies, Veristat integrates strategic planning, regulatory insight, and trial execution to overcome complex challenges and accelerate success. From early planning through approval, Veristat delivers tailored solutions that drive meaningful outcomes for patients worldwide.