Literature Monitoring Search Solutions & Alerts
Detect safety signals through systematic literature screening
Stay compliant with QbD Group's Literature Monitoring Services. Detect safety signals, ensure timely reporting, and enhance your vigilance strategy with systematic searches across scientific publications and databases.
What is Literature Monitoring?
Literature monitoring is the systematic and continuous review of scientific and medical publications to identify relevant safety information related to medicinal products. It is a regulatory requirement under Good Pharmacovigilance Practice (GPvP) and plays a vital role in maintaining an up-to-date safety profile for your products.
Our key services include:
- Systematic literature searches: Regular, structured searches across peer-reviewed journals, clinical databases, and scientific publications using validated search strategies.
- Safety signal identification: Identifying new or changing safety signals from published case reports, clinical studies, and epidemiological data.
- ICSR extraction from literature: Identifying and processing Individual Case Safety Reports found in published literature for regulatory submission.
- Alert management: Configuring automated alerts to ensure no relevant publication is missed, with timely escalation of critical findings.
- Regulatory compliance: Ensuring all literature monitoring activities meet EMA, FDA, and ICH requirements.
- Database coverage: Monitoring multiple databases including PubMed, Embase, and other specialized sources relevant to your therapeutic area.
Why is Literature Monitoring essential?
Regulatory obligation
Literature monitoring is mandated by GVP Module VI and global regulatory frameworks — non-compliance risks penalties and product recalls.
Signal detection
Published literature is a primary source for identifying new adverse reactions, interactions, and off-label use patterns.
Patient safety
Early identification of emerging safety concerns helps protect patients and enables timely risk mitigation.
Continuous safety profiling
Keeps your product's benefit-risk profile current throughout its lifecycle.
Global coverage
Systematic searches across international databases ensure comprehensive safety oversight across all markets.
How can we help?
QbD Group's Literature Monitoring services provide end-to-end support to keep your pharmacovigilance operations compliant and proactive:
Validated search strategies
Designing and executing product-specific literature search protocols across multiple databases.
ICSR extraction & reporting
Identifying valid ICSRs from published literature and processing them for regulatory submission.
Timely alert management
Configuring automated alerts and ensuring no relevant safety publication is missed.
Trend analysis
Analyzing literature trends to support signal detection and benefit-risk assessments.
Regulatory alignment
Ensuring all activities meet GVP Module VI, FDA, and ICH requirements.
Why QbD Group
Your trusted partner
Choosing QbD Group for literature monitoring ensures:
Expert pharmacovigilance team
trained professionals with deep knowledge of safety literature screening and ICSR extraction.
Comprehensive database coverage
systematic searches across PubMed, Embase, and therapeutic area-specific sources.
Regulatory compliance
processes aligned with GVP Module VI, FDA, and ICH guidelines.
Scalable solutions
flexible services that adapt to your product portfolio and therapeutic area requirements.
Seamless integration
literature monitoring that feeds directly into your broader pharmacovigilance operations.
Let's talk Pharmacovigilance
From QPPV services to signal management, our safety experts are ready to support your pharmacovigilance needs.