Veristat Debuts AI Biostatistics Platform That Significantly Cuts Trial Data Readout Time

Veristat has launched InStat, the clinical research industry’s first zero-code, fully automated biostatistics solution that reduces manual effort to speed time to approval, with every output backed by validated statistical engines and expert biostatistician review. InStat 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 began using InStat to deliver biostatistics services in June. Clene Nanomedicine is the first clinical trial sponsor whose work was delivered using InStat.

“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,” Clene Nanomedicine Chief Development Officer Michael Hotchkin 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. 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, according to the company. 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.

InStat enables transparent, collaborative readout reviews for better quality data, faster. Rather than sponsors 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 since 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,” Veristat Vice President of AI & Innovation Kyle McBride stated. “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.”

Veristat is a full-service contract research organization and consultancy that helps life sciences companies quickly bring novel therapies to market. 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.

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