Altasciences, a fully integrated early-phase drug development organisation, and Evidence Matters, a pioneer in clinical trial data science, announced 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.”