Fern.ai

Introduction to Fern.ai

Fern.ai is an AI clinical evidence platform designed to assist in the acquisition, analysis, and structuring of clinical evidence with the aim of simplifying the compliance process for medical documents. The platform addresses the challenges faced by regulatory compliance professionals, software engineers, and MedTech consultants by providing technology solutions that enhance the efficiency of bringing new medical device and diagnostic products to market.

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

The platform is developed to cater to the rigorous demands of clinical evidence review processes relevant to various healthcare regulatory standards, emphasizing reduction in research time, ensuring documents meet regulatory approval seamlessly, and maintaining accuracy and efficiency during the process.

Key Features

• Custom Templates & Research Strategy: Users can centralize all product details and incorporate AI into their project frameworks for a personalized approach.
• Smart Queries: Users can design search queries using their own set of keywords, benefit from automatic literature updates, and avoid duplicates with AI-powered detection.
• Intelligent Screening: The AI offers screening recommendations to facilitate inclusion and exclusion decisions, making the process quicker based on titles, abstracts, or full-text.
• Data Extraction: Utilizes advanced natural language processing (NLP) to assist in the literature review workflow and customizable extraction frameworks.
• Critical Appraisal: It provides pre-defined templates or custom grading systems to appraise full-text references efficiently.
• Audit-ready: The platform ensures an easy export of results, an auditable trail, and integration into existing reporting workflows.

Versatility and Practicality of Fern.ai

Fern.ai offers systematic literature review solutions that are tailored to specific research domains and objectives to ensure targeted and resourceful literature reviews. It caters to a range of compliance and reporting requirements, including:

• Clinical Evaluation Support for EU MDR: Customizable frameworks for medical device clinical and safety outcome measures to comply with Medical Device Regulation (MDR) requirements.
• Performance Evaluation Support for EU IVDR: Frameworks for in vitro diagnostics, encompassing analytical and clinical performance, as well as safety outcome measures in accordance with the In Vitro Diagnostic Regulation (IVDR).
• Health Economics and Outcomes Research (HEOR): Project frameworks for HEOR assessors including real-world data and clinical evidence.
• Epidemiology: AI framework to properly include articles addressing gaps in understanding of disease patterns and risk factors.
• Post-market Surveillance and Vigilance Reporting: Assisting in the identification of trends in adverse events for medical devices and ensuring regulatory compliance with periodic safety update reports.