Altasciences and Evidence Matters Advance AI-Driven Drug Development With Nonclinical Automation Breakthrough

Altasciences, a fully integrated early-phase drug development organization, and Evidence Matters, a pioneer in clinical trial data science, are pleased to announce a successful proof-of-concept (POC) of RegulatoryFlow (“RegFlow”), following the announcement of the companies’ strategic collaboration in August 2025. The POC demonstrated the extension of AI-driven efficiencies from clinical reporting into nonclinical workflows, marking a significant step forward in accelerating drug development timelines.

Building on proven results in clinical reporting, where the collaboration has achieved up to first-draft clinical study reports (CSRs), the teams have now successfully applied similar AI capabilities to nonclinical data through high-quality parsing of raw and SEND datasets in a proof-of-concept. This advancement aligns with the Altasciences Acceleration Platform, designed to fast-track drug development across the early-phase development continuum.

“This milestone reflects the power of integrated thinking in drug development,” said Marie-Hélène Raigneau, CEO of Altasciences. “By extending AI-driven efficiencies from clinical into nonclinical workflows, we are helping sponsors move from first safety assessments to clinical proof-of-concept, faster, accelerating timelines while maintaining scientific integrity.”

The POC revealed strong initial results, including accurate parsing of datasets and the potential to expedite and streamline nonclinical reporting workflows. This represents a first-of-its-kind AI bridge between nonclinical and clinical phases, enabling more efficient development pathways and freeing internal resources to focus on higher-value scientific work.

“The current version of RegFlow is already capable of generating approximately one-third of a typical nonclinical report with high fidelity,” noted Dr. Ofer Avital, MD, Founder and Director of Evidence Matters. “We are ready to deliver the results sections as well as a focused laboratory sciences subsection as the next key milestones.”

Recent platform enhancements, including the latest software release, continue to improve performance in clinical reporting, with early feedback indicating enhanced data mapping and usability. The collaboration continues to evolve to expedite drug development through AI.

“Together with Altasciences, we are redefining what’s possible in integrated development,” said Dr. Avital. “What began as a transformation in clinical reporting is now evolving into a broader framework for accelerating the entire early-phase journey. We believe this approach has the potential to set a new industry standard.”

About Altasciences

Altasciences is an integrated drug development organization offering pharmaceutical and biotechnology companies a proven, flexible approach to nonclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include nonclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. To learn more, visit altasciences.com.

About Evidence Matters and RegFlow

Evidence Matters is a leader in clinical trials data science, combining over 25 years of domain expertise with cutting-edge AI solutions. Its innovative RegulatoryFlow platform leverages near-deterministic Text Engineering to streamline and enhance regulatory writing—bridging the gap between data and documentation for life sciences teams worldwide. Originally rooted in healthcare, Evidence Matters has expanded its expertise across multiple industries, empowering organizations to transform complex data into actionable insights. Guided by a seasoned team of data scientists and industry leaders, Evidence Matters drives innovation and shapes the future of data-driven decision-making. To learn more, visit evidencematters.com/regulatoryflow.

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