Literature Monitoring Services
Enhance regulatory compliance with expert literature monitoring
Staying ahead of safety signals and medical information requires continuous monitoring of scientific literature. At QbD Group, our comprehensive Literature Monitoring Services ensure your product safety processes, applications, and equipment align with regulatory requirements. By systematically tracking relevant publications, we help you stay compliant, informed, and confident in your pharmacovigilance strategy.
What is literature monitoring?
Literature monitoring involves the systematic review of scientific journals, publications, and medical databases to identify safety information relevant to medicinal products or medical devices. This process plays a critical role in pharmacovigilance, enabling the timely detection of adverse events, safety signals, and new medical insights. Key aspects of literature monitoring:
- Global and local monitoring: Tracking publications from international and region-specific sources.
- Adverse event detection: Identifying and reporting safety signals or adverse drug reactions (ADRs).
- Medical information solutions: Extracting relevant clinical data to support product safety and regulatory submissions.
- Regulatory compliance: Ensuring alignment with EMA, FDA, and other global pharmacovigilance requirements.
- Customized reporting: Delivering tailored literature reports based on your product portfolio and markets.
Why is literature monitoring essential?
Scientific literature is a key source of safety data and medical insights. Effective monitoring ensures:
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Regulatory adherence: Meet mandatory reporting requirements for global health authorities.
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Early risk detection: Identify safety signals and adverse events promptly to protect patient safety.
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Informed decision-making: Leverage clinical data to improve pharmacovigilance strategies.
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Compliance confidence: Stay ahead of updates and requirements with accurate, timely monitoring.
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Enhanced safety assurance: Strengthen your product’s safety profile with continuous oversight.
How can we help?
Global and regional coverage
Adverse event identification
Adverse event identification
Detecting and reporting ADRs and safety signals to meet regulatory requirements.
Tailored search strategies
Tailored search strategies
Developing customized search terms to align with your products and processes.
Structured reporting
Structured reporting
Providing clear, actionable literature reports to integrate into your pharmacovigilance systems.
Inspection readiness
Inspection readiness
Preparing your organization for audits and inspections to ensure compliance.
Medical insights extraction
Medical insights extraction
Capturing valuable clinical information to support safety and regulatory submissions.
Why partner with QbD Group?
Partnering with QbD Group for Literature Monitoring Services ensures:
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Regulatory expertise: Decades of experience delivering compliant pharmacovigilance solutions.
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Global reach: Comprehensive monitoring of international and regional literature sources.
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Customized solutions: Tailored search strategies and reports based on your specific needs.
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Timely reporting: Accurate and prompt identification of safety information to meet reporting timelines.
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Trusted results: A proven track record of enhancing safety and regulatory compliance for clients worldwide.