Veristat officially launched its new AI-driven biostatistics platform called InStat today. This proprietary technology reduces clinical trial data readout times from five weeks to just five days. The platform achieves this speed without increasing regulatory risks for biopharmaceutical companies. InStat integrates advanced automation with professional oversight to ensure high data quality. Clene Nanomedicine is the first clinical trial sponsor to use the platform for its upcoming regulatory submission.
The platform delivered NfL biomarker concordance evidence to support Clene’s upcoming New Drug Application (NDA). These high-speed insights help life sciences firms make critical decisions sooner during drug development. The InStat platform provides sponsors with a competitive edge by delivering submission-ready data. Veristat uses a “human-in-the-loop” model where expert biostatisticians oversee every automated step. This ensures that AI speed never compromises the scientific integrity of the final results.
“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.”
Rapid Data Analytics and Regulatory Compliance
The system utilizes a secure environment to protect sensitive patient information. It maintains full traceability for all generated outputs. This ensures that every data point meets the strict requirements of health authorities. The platform allows sponsors to log into a secure portal to finalize readouts in real-time. By automating repetitive tasks, the technology reduces the chance of human error in complex calculations.
“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.”
The tool supports a wide range of therapeutic areas and trial phases. It connects directly with existing clinical data management systems. These advancements help bring life-saving treatments to market more rapidly. Veristat continues to invest in digital transformation to support its global clients. All processes remain compliant with international data standards. This launch marks a new era for biostatistical analysis in drug research. It helps sponsors meet their submission deadlines with higher confidence. Veristat remains committed to driving innovation across the clinical trial landscape.
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News Source: Businesswire.com
