Accelerating Clinical Trials with InStat: Transforming Data Readout from Weeks to Days
Veristat has introduced InStat, an AI biostatistics platform that significantly reduces the time required for clinical trial data readout from five weeks to just five days. This innovative solution delivers submission-ready tables, lists, and figures (TLF) using validated statistical engines, with Clene Nanomedicine being the first customer to benefit from this technology.
InStat by Veristat is a zero-code, fully automated biostatistics solution designed to streamline the process of generating submission-ready TLFs. By leveraging AI and expert biostatistician review, InStat can produce high-quality data outputs in a fraction of the time typically required after database lock, helping sponsors accelerate the approval process.
Veristat will begin offering biostatistics services using InStat in June, with Clene Nanomedicine already benefiting from the platform for their NfL biomarker analyses in preparation for a New Drug Application (NDA) submission. The use of InStat has enabled Clene Nanomedicine to expedite the delivery of critical data tables, supporting their accelerated approval pathway argument.
Traditionally, sponsors face significant delays in data analysis post-trial, which can result in substantial financial losses and prolonged patient suffering. InStat's automation capabilities eliminate these delays by utilizing AI agents to execute analytical steps efficiently, without the regulatory risks associated with manual analysis.
In addition to speeding up the data readout process, InStat facilitates transparent and collaborative reviews between sponsors and CROs, allowing for real-time feedback and finalization of biostatistical outputs. This system-agnostic platform ensures compatibility with various data capture systems and enables sponsors to maintain their preferred formatting.
Veristat's Vice President of AI & Innovation, Kyle McBride, emphasizes the transformative impact of InStat on biostatistical work in clinical research, highlighting the platform's AI-driven approach to enhancing speed and accuracy. By leveraging AI to assist biostatisticians in translating analytical intent into precise specifications, InStat ensures the reliability and efficiency of the entire data analysis process.
To learn more about InStat and its capabilities, interested parties can request a demo on a completed study. Veristat is also hosting an exclusive event featuring industry expert Ken Getz on May 18, 2026, in Boston, offering insights into the latest advancements in clinical research and biostatistics.
Veristat is a leading CRO and consultancy specializing in accelerating the development of novel therapies across various therapeutic areas. With a track record of success in regulatory approvals and a focus on patient-centric solutions, Veristat is committed to driving meaningful outcomes for patients worldwide through innovative clinical research practices.