Literature Screening and Review
Inspection-ready literature screening that protects patients and strengthens regulatory confidence
Qinecsa is the provider of choice for Literature Screening and Review, combining deep pharmacovigilance and scientific expertise with structured, technology-enabled processes to ensure no safety-relevant publication is missed. Our compliant, scalable approach reduces inspection risk, integrates seamlessly with ICSR Management and delivers proactive safety insight across global portfolios.
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What Is Literature Screening and Review And Why It Matters
Literature screening and review is the systematic identification, evaluation and documentation of scientific and medical publications to detect individual case safety reports, safety signals and information relevant for aggregate reports and benefit risk assessments. It is a mandatory component of global pharmacovigilance frameworks including EU GVP, FDA, MHRA and international regulations.
Organizations face increasing pressure from regulators to demonstrate that literature surveillance is continuous, well documented and applied consistently across regions and product portfolios. Failures such as missing publications, poor documentation or delayed reporting are among the most common inspection findings.
Qinecsa solves these challenges through a structured, compliant and scalable model that delivers:
- Continuous monitoring of global and local literature sources
- Clear screening strategies and full text review
- Expert medical and safety assessment
- Accurate identification of ICSRs and safety relevant information
- Seamless integration into case processing, aggregate reporting and signal activities
The result is stronger compliance, improved quality and proactive patient protection.
How Literature Screening and Review Fits Into Your Wider PV Strategy
Literature is one of the richest sources of emerging safety information and regulators expect it to be fully integrated into the pharmacovigilance system. Qinecsa ensures your literature surveillance links directly with case management, signal detection, safety review teams and periodic safety reporting.
This strengthens benefit risk assessments, supports earlier identification of trends and enhances the completeness of safety data used across your PV operations. It also ensures inspection teams see clear alignment between your literature processes and your broader safety governance structure.
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Why Qinecsa For Literature Screening and Review
Qinecsa brings deep scientific knowledge, global PV expertise and technology enabled oversight to deliver literature screening and review that is reliable, efficient and inspection ready.
Specialist Pharmacovigilance Expertise
Our reviewers combine scientific, medical and PV knowledge to accurately assess abstracts, full texts and safety content, ensuring high quality outputs across diverse therapeutic areas
Technology Enabled Delivery
Advanced search tools, structured workflows and digital quality controls ensure accuracy, traceability and consistency at scale
Global Reach With Local Insight
We screen international and regional literature, including specialized journals and local publications that regulators expect MAHs to monitor.
Regulator Ready Documentation And Governance
Documentation, audit trails, quality oversight and continuous monitoring are embedded from day one to support inspection readiness.
Qinecsa’s Approach To Literature Screening and Review
Our approach ensures comprehensive coverage, accuracy and seamless integration with your pharmacovigilance system.
Search Strategy Development
We build tailored search strategies aligned with your products, therapeutic areas and regulatory requirements, using databases such as Embase and PubMed.
Structured Screening And Assessment
Our experts conduct abstract screening and full text review to identify ICSRs and safety relevant content while removing irrelevant material
Full Text Retrieval And Translation
We procure full texts, perform translation where needed and prepare clear summaries for downstream PV activities
Integration With Your Safety Systems
Findings are delivered in formats compatible with your safety database and workflows, ensuring seamless case processing, aggregate reporting and signal management
Key Features Of Our Literature Screening and Review Solution
For Your Organization
- Compliance with global regulatory expectations
- Reduced inspection risk through structured documentation
- Scalable delivery across regions and therapeutic areas
- Consistent global processes with local flexibility
- Reduced risk of missed or delayed safety reporting
For Internal Teams
- Clear roles, visibility and governance
- Confidence in comprehensive, high quality surveillance
- Less operational pressure and workload
- Improved collaboration between safety, medical and regulatory teams
- Access to specialist expertise without adding headcount
For Patients And Healthcare Professionals
- Faster detection of emerging safety concerns
- Stronger signal evaluation and earlier intervention
- Improved benefit risk understanding
- Enhanced patient protection and safety outcomes
Benefits of Literature Screening and Review With Qinecsa
Organizational Benefits
- Stronger global compliance
- Consistent and repeatable processes
- Efficiency gains across PV operations
- Scalable support for evolving portfolios
Internal Team Benefits
- High operational clarity
- Reduced administrative effort
- Efficient collaboration
- Trust in expert review quality
Patient And HCP Benefits
- Rapid recognition of new risks
- Better informed safety decisions
- Improved health outcomes
- Stronger overall patient safety
FAQs - Literature Screening and Review
Literature Screening and Review is the systematic monitoring of scientific publications to identify safety information related to medicinal products. It is a regulatory requirement and a key source of safety data.
Regulators frequently review literature surveillance processes during inspections. Poor documentation or missed cases can lead to findings, making robust Literature Screening and Review essential.
Yes, Qinecsa supports global Literature Screening and Review aligned with EU, US, UK and international regulatory expectations.
Yes, many organizations outsource Literature Screening and Review to ensure consistency, scalability, and access to specialist expertise.
When reportable cases are identified, they are transferred into ICSR Management for processing and submission, ensuring end-to-end compliance.
When safety information pertinent to aggregate reports and signals is identified, this is transferred into medical safety teams for processing and submission, ensuring end-to-end compliance.
Absolutely. Outsourced Literature Screening and Review allows biotech organizations to meet regulatory requirements without building large internal teams.
Quality is ensured through trained reviewers, documented processes, quality checks, and continuous oversight.
Literature is screened continuously according to regulatory expectations and agreed search strategies.
Yes, search strategies and review processes are tailored to your products, indications, and markets.
Talk to a PV Specialist
Strengthen your pharmacovigilance system with expert literature screening and review that is compliant, efficient and inspection ready. Qinecsa provides the scientific expertise, global coverage and integrated technology needed to ensure emerging safety information is captured and acted upon with confidence