AI-Powered Literature Monitoring

DrugCard's AI-Powered Literature Monitoring is a SaaS platform designed for pharmacovigilance teams that need to automate the screening and review of global and local medical literature. It replaces manual literature surveillance workflows with automated processes, covering sources across 121+ countries and 2,200+ continuously monitored local journals, including PubMed full texts and non-indexed local publications.

The platform is intended for PV teams seeking to reduce time spent on repetitive screening tasks, maintain compliance with global pharmacovigilance standards, and ensure complete traceability of all literature review activities. Every client receives a tailored source list with country-specific recommendations, and new journals can be added without lengthy administrative processes.

Key Platform Benefits

• Unifies global and local publication monitoring into a single standardized workflow, applying the same process quality regardless of source type or geography.
• Automates repetitive literature screening, allowing PV experts to focus on signal detection, risk assessment, drug safety documentation, and scientific evaluation.
• Captures all published articles automatically, with full traceability of results to reduce the risk of missed publications.
• Provides real-time visibility into every task, action, and screening step, with automatic activity recording that generates audit-ready evidence without manual paperwork.
• Protects PV data through FDA 21 CFR Part 11–compliant records and signatures, with a certificate of conformity applicable in the EU, US, and CIS regions.
• Hosted on ISO/IEC 27001:2013 and SOC 2 Type II infrastructure for enterprise-grade data security.
• Available 24/7 on any device as a SaaS solution, supporting distributed teams across regions and time zones.

Core Features for Literature Screening

• AI Article Summaries: Automatically generates summaries of relevant articles so reviewers can assess content without reading full texts.
• AI Pre-Assessment of Safety Relevance: Identifies whether an article contains safety-relevant references or safety signals and prioritizes it accordingly.
• One-Click Case Creation: Converts an article into an individual case safety report in a single click, integrated with the DrugCard adverse event database.
• Automatic Translation of Local Sources: Supports over 100 languages, making local literature accessible without requiring external translation tools.
• Validated, Audit-Ready Platform: Has passed regulatory inspections and audits, with reliability confirmed by regulatory authorities.
• Flexible Project Configuration: Supports multi-country, multi-client setups with configurable roles, source lists, and monitoring requirements.

How the Platform Works

1. Create a project: Select countries, define coverage scope (global or local publications), and specify the products to monitor.
2. Get instant results: The system processes sources immediately upon setup, with no manual runs or waiting periods required.
3. Stay updated automatically: Receive real-time notifications about new findings and weekly automated reports for ongoing oversight.

Compliance and GVP Controls

• Includes controls for GxP activity and good pharmacovigilance practice (GVP).
• Provides role-based user access control and structured, comprehensive screening results.
• Generates automatic aggregate reports, including search strategy documentation.
• Maintains a complete audit trail without requiring manual file downloads or reviews.
• Supports keyword highlighting and weekly reports alongside real-time notifications for continuous literature surveillance.

DrugCard is deployed as a cloud-based SaaS platform and integrates literature monitoring with an adverse event database for direct case report creation. The platform has been validated through regulatory inspections and is suitable for use across the EU, US, and CIS markets.