Delivers Audit-Ready, Exportable Clinical Evidence in 60 Percent Less Time Than Manual Processes and 40 Percent Less Time Than Alternative Technology Platforms

RQM+, the world’s leading MedTech service provider, today announced the launch of Fern.ai, the first human-in-the-loop artificial intelligence (AI) platform that standardizes all aspects of clinical evidence literature review for regulatory affairs professionals – delivering audit-ready, exportable results in 60 percent less time than a manual process and 40 percent less time than alternative technology platforms. Fern.ai is the first offering from RQM+ Technology Solutions, an independent business unit dedicated to helping the life sciences community improve patient outcomes by bringing life-improving products to market more quickly and efficiently through advanced technology platforms.

“Fern.ai empowers clinical, quality and regulatory affairs professionals to focus on quality by automating laborious and frustrating tasks through its human-in-the-loop AI technology,” said RQM+ CEO Margaret Keegan. “With the largest global team of MedTech regulatory and quality consultants, RQM+ is in the best position of any organization to identify time-consuming bottlenecks in the regulatory process and design technologies to eliminate those frustrations for the regulatory community. Through our Technology Solutions business unit, we are proud to introduce platforms like Fern.ai that give regulatory professionals the freedom to focus on strategic, scientific tasks and the confidence to know that the clinical evidence they submit meets the highest quality standards.”

Fern.ai is the only comprehensive platform that covers the entire clinical evidence evaluation process, including literature review strategy, queries, screening, appraisal and data extraction from full-text articles. Through digitization, automation and integration, Fern.ai helps MedTech companies, regulators and service providers generate audit-ready documents in 60 percent less time than a traditional, manual process and 40 percent less time than alternative technology platforms.

“We refer to Fern.ai as human-in-the-loop AI technology because the platform empowers the user by providing recommendations,” said Chief Digital and Technology Officer Alaric Jackson. “Fern.ai streamlines your process, ensures consistency and reduces errors by handling laborious and repetitive tasks, such as screening references and data extraction, but keeps you in the driver’s seat by letting the user make the final call on all recommendations. The judgment and expertise of a highly skilled regulatory professional is irreplaceable and critical to achieve a successful outcome. In addition, Fern.ai learns from these interactions – making the whole end-to-end process increasingly efficient and delivering a high-quality outcome.”

Fern.ai was originally developed in 2020 by Giotto.ai and marketed as Giotto Compliance. RQM+ acquired Giotto Compliance in February 2023.

For more information, visit Fern.ai or the Fern.ai booth at MedTech Summit in Brussels from June 19-23.

About RQM+

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab, and reimbursement services, and technology solutions – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. In addition to early- and mid-stage MedTech companies, we currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies. For more information, visit RQMplus.com.

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