Altasciences, a contract research and manufacturing organization specializing in early-phase drug development, has announced a collaborative effort with Evidence Matters to advance methods in regulatory documentation. The partnership seeks to integrate Altasciences’ experience in clinical development with Evidence Matters’ proprietary Text Engineering technology, which aims to reduce variability and increase efficiency in the preparation of regulatory submissions.
“We are excited to work alongside Evidence Matters to co-develop technology that directly enhances the quality and efficiency of regulatory writing. Through this partnership, we’re not just implementing AI, we’re actively shaping its future as an indispensable tool in life sciences.”
Nicole Maciolek, Vice President, Research Services at Altasciences.
The collaboration centers on Evidence Matters’ RegulatoryFlow platform, designed to unify clinical datasets and documentation, streamline workflows, and mitigate common errors in regulatory writing. Initial evaluations of the technology, according to Evidence Matters, have demonstrated improvements in accuracy, including the removal of frequent table transfer errors and a greater than 50% reduction in time required to process tables, figures, and listings into submission-ready formats.
“With Text Engineering, we’re moving beyond automation into a new era of precision and consistency. The impact on regulatory documentation, from timelines to accuracy, is transformative. In testing against manual work, RegulatoryFlow demonstrated the elimination of table transfer errors that can touch approximately one-third of tables in life science regulatory documents, while reducing TFL-to-Word processing time by more than 50%.”
Dr. Ofer Avital, Founder and Director of Evidence Matters.
Altasciences is providing real-world data and conducting user testing to refine the platform for operational use, emphasizing integration within existing document preparation environments rather than the introduction of new enterprise systems. According to the collaborators, this approach enables rapid deployment and facilitates adoption by medical writing and regulatory teams.