Altasciences and Evidence Matters Achieve AI Breakthrough in Nonclinical Drug Development Automation
Key Insights
Altasciences (search) and Evidence Matters (search) announced a successful proof-of-concept for extending their AI-driven RegulatoryFlow (search) platform from clinical reporting into nonclinical workflows.
The proof-of-concept demonstrated accurate parsing of raw and SEND datasets, with the current RegFlow version capable of generating approximately one-third of a typical nonclinical report with high fidelity.
This represents a first-of-its-kind AI bridge between nonclinical and clinical phases, enabling more efficient development pathways and faster drug development timelines.
Altasciences (search), a fully integrated early-phase drug development organization, and Evidence Matters (search), a pioneer in clinical trial data science, have announced a successful proof-of-concept (POC) of their RegulatoryFlow (search) ("RegFlow") platform, extending AI-driven efficiencies from clinical reporting into nonclinical workflows. The milestone, which follows the companies' strategic collaboration announced in August 2025, marks a significant step forward in accelerating drug development timelines across the early-phase continuum.
The POC builds on proven results in clinical reporting, where the collaboration has already 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. This advancement aligns with the Altasciences (search) 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 (search). "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."
Proof-of-Concept Results and Platform Capabilities
The POC revealed strong initial results, including accurate parsing of datasets and the potential to expedite and streamline nonclinical reporting workflows. According to Dr. Ofer Avital, MD, Founder and Director of Evidence Matters (search), "The current version of RegFlow is already capable of generating approximately one-third of a typical nonclinical report with high fidelity." Dr. Avital further noted that the teams are "ready to deliver the results sections as well as a focused laboratory sciences subsection as the next key milestones."
This advancement represents what the companies describe as 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 RegulatoryFlow (search) platform leverages near-deterministic Text Engineering to streamline and enhance regulatory writing, bridging the gap between data and documentation for life sciences teams worldwide.
Platform Evolution and Industry Impact
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 with the goal of expediting drug development through AI.
"Together with Altasciences (search), 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."
Altasciences (search) brings over 30 years of experience partnering with sponsors to support educated, faster, and more complete early drug development decisions. The organization's 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. Evidence Matters (search) combines over 25 years of domain expertise with cutting-edge AI solutions, empowering organizations to transform complex data into actionable insights.