Literature Monitoring
Automation

Compliance First, AI Enabled Turning Literature into Actionable Safety Insights

 

Identifying New Safety Signals

Literature search helps to identify new safety signals or adverse reactions associated with medicinal products that may not have been previously reported.

Supporting Signal Detection

Literature search provides valuable data to support signal detection activities, enabling pharmacovigilance teams to prioritize and investigate potential safety concerns.

Informing Regulatory Decisions

Identifying and categorizing named entities (e.g., people, organizations, locations) Literature search and monitoring inform regulatory decisions, such as label updates, risk management, plan development, and product recalls.

Features

Defining Search Parameters

Define search parameters, including databases, search terms, and time frames, to ensure a comprehensive and targeted search.

Searching Databases

Search various databases, such as PubMed, Embase, and Scopus, to identify relevant articles.

Screening and Filtering

Screen and filter search results to identify articles relevant to the medicinal product or safety concern.

Assessing Article Relevance

Assess the relevance of articles based on predefined criteria, such as study design, population, and outcome measures.

Extracting and Analyzing Data

Extract and analyze data from relevant articles, including adverse reaction information, study results, and study limitations.

Reporting and Documenting

Report and document literature search findings, including any identified safety concerns or signals.

Literature Monitoring & Surveillance Features

Literature Search

  • Search Query Construction
  • Saved Searches
  • Supports all types of Queries
  • Filtered and Federated Searches
  • Global Search from single page
  • Indexing Engine for Local Literatures
  • User Defined Local Search Collections

Literature Review

  • Full-Text Literature Review
  • AI-Based Information Extraction
  • Four Minimum Criteria Validation
  • Automated Screening & ICSR Detection
  • Case Detail Extraction
  • Additional Powertools for Annotation
  • AI-Powered Literature Quality Assessment

Literature Monitoring

  • Continuous Monitoring & Data Ingestion
  • Automated Search Scheduling
  • Duplicate Identification
  • AI-Powered Configurable Decision Engine
  • Safety Signal Monitoring
  • AI-Based Duplicate Identification
  • System Monitoring, Alerts & Notifications

Literature Management

  • Audit & Compliance Ready
  • Literature Source Management
  • Case Lifecycle Management
  • Collaborative/Review Support
  • Knowledge Management & Data Organization
  • Data Analysis & Reporting
  • Human-in-the-Loop Support

Global Literature Monitoring

Continuous surveillance of international scientific publications to identify potential safety info related to medicinal products.

Global Literature Sources

(Not Limited to)

  • PubMed / MEDLINE
  • Embase
  • Scopus
  • Web Of Science
  • Cochrene Library
  • Clinical Research Publications

Multi-Database Search

Simultaneous monitoring of multiple global scientific databases to ensure comprehensive literature coverage.

Automated Search Strategy

Configurable search strategies automatically run across global literature sources on defined schedules.

AI Screening

Artificial Intelligence automatically screens publications to identify safety-relevant literature with precision.

Deduplication Identification

Advanced algorithms automatically remove duplicate records across multiple databases for clean results.

ICSR Detection

AI identifies potential Individual Case Safety Reports (ICSRs) from scientific literature automatically.

Automated ICSR Data Processing

Our AI-Enabled ICSR processing engine extract all the relevant information and generate E2B R3 XML files in minutes.

Local Literature Monitoring

Focused identification of safety information published in regional journals and country-specific publications not limited to National Medical Journals, Local Language Publications, Regional Conference Abstracts.

Regional Journal Monitoring

Monitoring national medical journals and regional publications for country-specific safety data.

Local Regulatory Compliance

Tracking government health bulletins and local regulatory literature requirements per region.

Multilingual Processing

Advanced multilingual processing to handle local language publications and regional abstracts.

Country-Specific Surveillance

Regional adverse event detection and local safety signal identification per country.

AI Capabilities

Our framework delivers a structured, AI-Powered pipeline that automates the complete lifecycle of literature monitoring - from intelligent search to safety intelligence using advanced artificial intelligence and NLP models.

Literature Discovery

  • Search Strategy Management
  • AI-Powered Query Builder
  • Automated Scheduling

AI Literature Screening

  • Relevance Classification
  • AI-Powered Screening
  • Multi-Case Identification

Safety Detection

  • ICSR Identification
  • Seriousness Assessment
  • Full-Text Review

ICSR Processing & Data Extraction

  • Patient/Reporter/Drug/Event Extraction
  • Case Validation & Triage
  • Literature-to-Case Linking

Safety Intelligence & Regulatory Reporting

  • Safety Signal Monitoring
  • Alerts & Notifications
  • Regulatory Reporting Support

Compliance First Platform

The Compliance First Platform in pharmacovigilance embeds regulatory adherence into every process to safeguard patient safety. It delivers transparent, auditable workflows that ensure trusted oversight of drug safety monitoring.

Audit Ready Software. Every action is recorded as per the audit requirements and always ready for auditing.

All Major Regulatory Compilance. Multi-Country, Multi-Regulatory support. Periodic updates of the guidelines.

Secure Data Processing & Storage. SSH, Database Encryption, Multi-Tenant, HIPAA, SOC2.

21 CFR Part 11& EU GvP Compliant. The platform is assuring the reliability of electronically produced records and signatures.

Seamless Integrations. Smarter Safety.

Seamlessly connect with leading pharmacovigilance systems and data formats

Oracle Argus
ARISg
Veeva Vault
Excel & CSV
E2B R3 XML
Databases

Benefits

AI First Approach

Leverage AI-driven Search & Monitoring to screen global scientific databases, ensuring comprehensive and continuous literature coverage.

End-To-End Automation

Streamlined workflows through complete automation, reducing errors and increasing productivity without any manual touch.

Faster Onboarding

Accelerating the client onboarding process through streamlined workflows, automation, and standardized procedures.

Accuracy Guarantee

Achieve high precision in literature screening and adverse event detection with AI-assisted processing and validation.

Cost Effective

Reduce operational costs by minimizing manual effort, optimizing resources, and improving overall productivity.

Build For Your Needs

Our approach lets you customize our solutions to fit your unique customer requirements.

Manual Monitoring vs AI Monitoring

See the difference automation makes

Traditional Approach

  • Manual Database Searches Repeated manual queries with no automation
  • Time Consuming Screening Hours spent reviewing each publication
  • Limited Publication Reviewed Restricted scope due to manual capacity
  • List of Missing Safety Cases Human error leads to ICSR oversight
  • High Operational Effort Large teams required for full coverage

vGenix AI Offerings

  • Automated Literature Discovery AI queries run 24/7 across all databases
  • AI Powered Rapid Screening AI models classify relevance instantly
  • Thousands of Publications Processed Full global & regional coverage achieved
  • Intelligent ICSR Detection AI flags and extracts safety cases automatically
  • Continuous Safety Monitoring Real time signals, alerts and reporting

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