Literature Monitor

Datafoundry's Literature Monitor is an AI-powered literature monitoring solution designed for pharmacovigilance and cosmetovigilance professionals. It automates the process of searching, screening, and processing published literature to support safety vigilance, adverse event identification, and regulatory compliance. The solution is modular and scalable, and is built to integrate with leading safety databases and signal management products.

The tool addresses core challenges faced by pharmaco- and cosmetovigilance teams, including the growing volume of published literature, the burden of regulatory compliance, the time and resource demands of manual screening, difficulties in team collaboration, and the need for real-time safety alerts. By automating key steps in the literature monitoring workflow, Datafoundry's Literature Monitor aims to reduce time and manual effort by up to 60% and improve the efficiency of the overall process by up to five times.

Key Challenges Addressed

• Increasing volume of literature makes it difficult to identify relevant safety information
• Compliance with regulatory requirements is resource-intensive
• Manual screening is time-consuming and prone to error
• Collaboration and communication among team members is difficult to coordinate
• Real-time alerts and notifications are needed to address safety concerns promptly

Core Features

• Semantic search across all major global and local literature databases simultaneously for article retrieval
• Articles ranked by relevancy based on potential adverse events and date of publication
• Named Entity Recognition (NER) and NLP models for highlighting safety-related information within articles
• Extraction of safety entities and auto-population of safety case forms
• Entity tagging for structured identification of safety information
• Automated de-duplication to prevent repeated processing of the same articles
• Automated translation of abstracts and full articles into English to support multilingual monitoring
• Configurable workflows, alerts, and notifications to support team collaboration and quality control
• One-click submission of case forms to safety databases in E2B R2/R3 or Excel/PDF formats

Capabilities and Benefits

• Efficiency: Reduces time and manual effort in literature monitoring by up to 60%, with an overall process efficiency improvement of up to five times
• Accuracy: NER-based highlights ensure minimum safety information is extracted accurately from articles, reducing the risk of errors
• Regulatory compliance: Data extraction into adverse event forms supports upload to safety databases in E2B R2/R3 format, aligning with regulatory requirements
• Customization: Workflow and product configuration modules in the admin interface allow the solution to be adapted to the specific needs of pharmacovigilance teams
• Multilingual support: Automated article translation removes language barriers, enabling monitoring of literature published in multiple languages
• Zero duplication: Automated duplicate search prevents information from being processed more than once, saving time and effort
• Cost reduction: Automated processes and improved efficiency can help reduce operational costs for pharmacovigilance departments

Integration and Deployment

• Integrates with all major global and local literature sources for simultaneous article download
• Compatible with leading safety databases and signal management products
• Supports case form submission in E2B R2/R3, Excel, and PDF formats
• Modular and scalable architecture to accommodate varying organizational needs

Datafoundry's Literature Monitor is part of Datafoundry's broader suite of AI-driven safety and vigilance solutions, which also includes Signal AI, CosmetoShield AI, DF Safety AI, and DF Digitalize AI. The solution is targeted at pharmacovigilance and cosmetovigilance teams in pharmaceutical and cosmetics organizations seeking to automate and standardize their literature surveillance processes.