Regulatory Affairs
Altasciences and Evidence Matters Announce Strategic Collaboration to Advance AI-Enhanced Text Engineering for Regulatory Writing in Life Sciences
Laval, Québec, August 27, 2025 — Altasciences, a fully integrated CRO/CDMO offering comprehensive early-phase drug development solutions, is pleased to announce a strategic collaboration with Evidence Matters, a pioneer in clinical trial data science and document engineering.
This partnership combines Altasciences' real-world drug development expertise with Evidence Matters' innovative, patent-pending Text Engineering technology—a breakthrough that delivers near-deterministic accuracy in regulatory writing by reducing variability and improving the quality, consistency, and speed of documentation.
Evidence Matters' RegulatoryFlow platform (“RegFlow”) and specialized services unify clinical data and documents, simplify workflows, and accelerate the work of key life sciences professionals, from medical writers to regulatory specialists.
“We are excited to work alongside Evidence Matters to co-develop technology that directly enhances the quality and efficiency of regulatory writing,” said Nicole Maciolek, Vice President, Research Services at Altasciences. “Through this partnership, we’re not just implementing AI, we’re actively shaping its future as an indispensable tool in life sciences.”
Altasciences is deeply engaged in the partnership, contributing real-world training data and conducting user testing to help ensure the technology meets the needs of frontline teams. This collaboration underscores Altasciences' ongoing commitment to leveraging artificial intelligence to drive innovation, streamline complex processes, and deliver better outcomes for both sponsors and patients.
"With Text Engineering, we're moving beyond automation into a new era of precision and consistency," said Dr. Ofer Avital, Founder and Director of Evidence Matters. "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. Avital also added, “Unlike traditional enterprise platforms that require extensive implementation timelines, RegulatoryFlow integrates seamlessly with existing Microsoft Word workflows, enabling rapid deployment in weeks rather than months, and meets medical writers right where they work."
Together, Altasciences and Evidence Matters are redefining what's possible in clinical trial implementation and documentation, helping sponsors move faster, and with greater confidence, from candidate selection to clinical proof of concept, and beyond.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical 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 preclinical 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. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more, visit altasciences.com.
Julie-Ann Cabana
Altasciences
media@altasciences.com
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