Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application

Veristat’s InStat™ delivers submission-ready tables, listings, and figures (TLFs) in one week using validated statistical engines, shortening the critical path from database lock to submission

SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes.

Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks to regulatory approval. To remove this barrier, Veristat uses its AI-enhanced platform to compress the timeline to submission-ready TLFs from weeks to days, with every output validated by statistical engines, fully traceable, and reviewed by Veristat expert biostatisticians.

For Clene, InStat delivered lightning-fast neurofilament light (NfL) biomarker analyses at the center of its New Drug Application for CNM-Au8 in amyotrophic lateral sclerosis (ALS), submitted in October 2026 under the accelerated approval pathway. When the volume of analyses required for the filing expanded beyond the original plan, InStat allowed the company to take on the added work and still submit in 2026.

“Veristat moved at unprecedented speed, eliminating weeks of hand-programming that is also the source of most errors,” said Rob Etherington, CEO of Clene Nanomedicine. “Every minute from database lock to submission matters. InStat enabled us to move from locked data to reviewable NfL biomarker tables in days, allowing for concurrent review and verification of the outputs instead of waiting until the end of a long cycle. That kind of speed, with the rigor we require, is what lets us keep pace with the urgency of ALS.”

At study close, sponsors can wait months 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 by leveraging 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. And because InStat is system-agnostic, sponsors can use their preferred electronic data capture system and maintain their unique formatting.

Veristat’s work for Clene spanned a dozen deliverables, each with its own statistical analysis plan, and the company is now seeing the same results on two studies for a second sponsor.

“Everyone hoped AI would bring speed, but quality may be the bigger story,” said Kyle McBride, Veristat Vice President of AI & Innovation. “In every side-by-side comparison with traditional hand programming, any discrepancies traced back to the manual side, never to InStat. An error in an NDA puts an approval at risk. While much of the industry is still working on either speed, quality, or compliance, we’ve solved all three. Faster used to mean riskier. Not anymore, and that means new therapies can reach patients sooner.”

About Veristat Veristat is a full-service contract research organization and consultancy with 30+ years of experience and deep expertise in rare disease, neurological disease, oncology, and other complex modalities. Veristat integrates strategic planning, regulatory insight, data analysis, medical writing, and trial execution to overcome one-of-a-kind challenges and accelerate success. The company has supported more than 500 regulatory submissions globally. From early planning through approval, Veristat delivers tailored solutions and leverages advanced technologies that drive meaningful outcomes for patients worldwide.