Stress-free compliance.

Meet Fern.ai, the clinical evidence platform.

Fern.ai reduces research and regulatory burdens so your documents get approved without debate.

Collecting, analyzing, and structuring clinical evidence can be stressful.

Alleviate the stress with the only platform that covers the full spectrum of clinical evidence from strategy to analysis.

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Custom Templates & Research Strategy

Centrally capture all product details to streamline development of your literature search strategy and 100% control to configure AI in project frameworks.

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Smart Queries

Easily design search queries using your own keywords and keep track of the latest literature with automatic updates and AI-powered duplicate detection.

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Intelligent Screening

Reduce your screening time with AI-based recommendations and perform inclusion and exclusion decisions based on titles, abstracts, or full-text.

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Data Extraction

Save time and effort in your literature review workflow thanks to our advanced natural language processing (NLP) technology and customizable extraction frameworks.

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Critical Appraisal

Quickly and easily appraise full-text references for regulatory reports using either our pre-defined templates or your own custom grading system.

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Audit Ready

Streamline your literature review process with easy results export, an auditable trail, and proven integration into your existing reporting workflow.

About Fern.ai

We’re a team of regulatory compliance experts, software engineers, and MedTech consultants who are committed to leveraging leveraging technology to help our clients bring better medical device and diagnostic products to market, faster. To learn more about our company and platform, visit our About Us page.

Product Demo Video

See Fern.ai in action 

Ready to see Fern.ai in action? Book a live demo today and see how Fern.ai can reduce the research and regulatory burdens. 

Use cases for Fern.ai

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Systematic Literature Review

Fern.ai offers customized systematic literature review solutions. 

Our comprehensive workflow covers project organization, queries, screening, appraisal, extraction, and exported results providing data and an audit trail of your literature review. 

We tailor our automated data extraction and organization tools to specific research domains and objectives, ensuring a targeted and efficient literature review process.

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Clinical Evaluation Support for
EU MDR

Our medical device extraction framework can be customized to include clinical and safety outcome measures for any medical device type so that this content is extracted from included articles consistently.

We offer clinical evidence review templates, appraisal guidance, and customizable exports to streamline the creation of clinical evaluation reports ensuring adherence to MDR requirements.

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Performance Evaluation Support for EU IVDR

Our IVD extraction framework can be customized to include analytical performance, scientific validity, clinical performance, and safety outcome measures for any IVD product type creating a seamless extraction from included articles.

We offer performance evidence review templates, appraisal guidance, and customizable exports to streamline the creation of performance evaluation reports ensuring adherence to IVDR requirements.

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Health Economics and Outcomes Research

Selecting appropriate study designs, outcome measures, and search parameters for Health Economics and Outcomes Research (HEOR) assessments are critical to ensure healthcare decisions are informed from rigorous methodologies.

We provide customizable project frameworks that emphasize the incorporation of real-world data and clinical evidence, leveraging patient-level data, observational studies, and pragmatic trial data to enhance the rigor and validity of your health economic and outcomes research methodology.

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Epidemiology

Conducting epidemiological studies involves analyzing disease patterns, risk factors, and treatment outcomes, which can be complex and time-consuming due to the need for comprehensive data analysis and evidence synthesis.

Streamline your clinical evidence review with Fern.ai and leverage the AI framework to include articles in your clinical evidence review that address gaps in understanding so you don’t miss articles that may lead to understanding of disease prevalence, incidence, or associated risk-factors.

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Post-Market Surveillance and Vigilance Reporting

Use Fern.ai to identify trends in adverse events, device malfunctions, or off-label use to avoid time-consuming searches that if not completed, or not completed correctly, could lead to regulatory non-compliance.

The clinical evidence review process in Fern.ai supports quick and automated literature searches on a cadence you set. This way current literature review data can be included in Periodic Safety Update Reports, Post Market Surveillance Reports, and for ongoing vigilance reporting.

Who We’ve Helped

At Fern.ai, we serve a diverse range of clients, including regulatory bodies and MedTech companies. Our platform is trusted by regulators and industry leaders for its accuracy, efficiency, and ease of use. Our clients include:

enerxen

"Fern.ai helped us improve the review process while dramatically reducing the screening time and enhancing collaboration by using a centralized cloud system, overall a value-generating experience."

Mauricio Rodriguez

Managing Partner

ward 247

"Fern.ai is an excellent all-in-one platform. It was easy implement search strategy words and easy to see which articles were included and excluded. Data extraction to PRISMA diagrams is a brilliant solution, and the time spent on literature reviews was greatly reduced with Fern.ai."

Christian Meyhoff

Founder, Board Member

ppl biomechanics

"We used the Fern.ai Platform to complete our MDR literature review in December 2021. The software was easy to use and resulted in a dramatic reduction in the time required to complete our literature search. The Fern.ai team were very professional, friendly and made themselves available for help and support."

Christine Kieman

Education Officer

diagnosys

"Our company recently discovered Fern.ai to test how it would fare for our niche medical device in preparation for the literature review for our clinical evaluation report. (...) the ability to verify and validate the data in half the time made the decision to purchase. The platform is easy to navigate and the support team is top-notch."

Cathleen Stone

Business Process Coordinator

Our Resources

Gain valuable insights into best practices, industry trends, and how Fern.ai can make your workflow 40% more efficient by browsing webinars, blog posts, case studies, and other informative resources.

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Have questions?

Ready to make your regulatory processes faster, easier, and more efficient?

Book a demo or register for a free trial to see how the end-to-end Fern.ai solution uses AI to get your submissions done faster and more accurately without taking the human out of the loop.