RQM+, a renowned MedTech service provider, has announced the launch of Fern.ai, an innovative human-in-the-loop AI platform that revolutionizes the standardization of clinical evidence literature review for regulatory affairs professionals. By automating laborious tasks and leveraging advanced AI technology, Fern.ai significantly reduces the time required for the review process, surpassing manual methods by 60 percent and alternative technology platforms by 40 percent. This groundbreaking solution is the inaugural offering from RQM+ Technology Solutions, a dedicated business unit committed to advancing technology platforms that accelerate the delivery of life-improving products to market, ultimately enhancing patient outcomes.
Margaret Keegan, CEO of RQM+, highlighted the transformative capabilities of Fern.ai, stating, “Fern.ai empowers clinical, quality, and regulatory affairs professionals by automating arduous and time-consuming tasks through its human-in-the-loop AI technology. As the leading global team of MedTech regulatory and quality consultants, RQM+ is uniquely positioned to identify bottlenecks in the regulatory process and develop technologies to alleviate these challenges for the regulatory community. Through our Technology Solutions business unit, we take pride in introducing platforms like Fern.ai, which enable regulatory professionals to focus on strategic and scientific tasks while ensuring that the clinical evidence they submit adheres to the highest quality standards.”
Fern.ai stands out as the most comprehensive platform available, encompassing the entire clinical evidence evaluation process. From literature review strategy and queries to screening, appraisal, and data extraction from full-text articles, the platform digitizes, automates, and integrates each step. By leveraging these advanced capabilities, Fern.ai empowers MedTech companies, regulators, and service providers to generate audit-ready documents in significantly less time compared to traditional manual methods and alternative technology platforms.
Alaric Jackson, Chief Digital and Technology Officer, described Fern.ai as “human-in-the-loop AI technology” due to its ability to provide recommendations while keeping the user in control. The platform streamlines processes, ensures consistency, and reduces errors by automating repetitive tasks such as screening references and data extraction. However, it acknowledges the irreplaceable judgment and expertise of highly skilled regulatory professionals, allowing the user to make the final decisions. Moreover, Fern.ai continuously learns from these interactions, continuously improving the end-to-end process and delivering high-quality outcomes.
Originally developed as Giotto Compliance by Giotto.ai in 2020, Fern.ai joined the RQM+ family after RQM+ acquired Giotto Compliance in February 2023. This strategic acquisition strengthens RQM+’s position as an industry leader in providing cutting-edge solutions for the regulatory affairs community. Fern.ai, with its advanced AI capabilities, is set to transform the clinical evidence review landscape and drive efficiency and accuracy for regulatory professionals worldwide.
