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Our teams are trained to identify and extract safety-relevant information from literature sources, ensuring accurate and compliant reporting into pharmacovigilance systems.
Literature Monitoring & Surveillance
Proactive Safety Intelligence from Global Scientific Sources
Ensure continuous monitoring
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Medical literature is a critical source of safety information and plays a key role in maintaining an accurate and up-to-date benefit–risk profile of medicinal products. Baupharma’s literature monitoring services are designed to systematically identify, evaluate, and report safety data from global and local sources, ensuring continuous compliance with pharmacovigilance services requirements.
1000+Sources of literature
screening Monthly
screening Monthly
We deliver high-quality, audit-ready outputs that support both regulatory obligations and strategic decision-making by combining:
- Scientific Expertise
- Structured Methodologies
- Advanced Tools
Global Literature Surveillance
Baupharma conducts structured and periodic searches across major biomedical databases such as PubMed, Embase, and Medline to identify relevant publications, including potential safety cases and emerging risks.
Identification of Individual Case Safety Reports (ICSR)
Detection of safety signals and emerging trends supporting Signal Management
Abstract review and relevance assessment based on GVP criteria
Local Literature Monitoring
Baupharma's services extend beyond indexed databases to include non-indexed journals, regional publications, and country-specific sources. This ensures comprehensive coverage across all markets where products are authorized.
Local Intelligence.
Global Reach.
Global Reach.
Monitoring of local journals and scientific publications
Multilingual review by local experts and native speakers
Coverage tailored to therapeutic areas and product portfolios
Coordination between global and local teams for consistent outputs
Targeted & Ad Hoc Literature Searches
Baupharma performs customized literature searches to support specific pharmacovigilance activities, regulatory submissions, and safety evaluations.
- Signal detection and validation activities
- Support for aggregate reports (e.g., PSUR/PBRER, DSUR)
- Literature reviews for risk management and benefit–risk evaluation
- Investigation of specific safety concerns or product queries
Safety Data Extraction & Case Identification
Identification and processing of reportable safety cases
Classification of special situations (e.g., off-label use, misuse)
Integration with case processing workflows
Timely escalation and reporting in line with regulatory timelines
Integrated Signal Management & Risk Evaluation
Literature monitoring that is fully aligned with broader pharmacovigilance activities, contributing directly to signal detection, risk management, and safety communication strategies.
Our Strategy includes:
Input into signal detection and validation processes
Support for benefit–risk assessments across the product lifecycle
Contribution to post-authorization safety studies (PASS)
Evidence generation for regulatory and clinical decision-making
Technology-Enabled Monitoring & Quality Control
Baupharma leverages a combination of automation and expert medical review to enhance efficiency while maintaining high data quality.
Our Approach includes:
Automated search strategies combined with manual validation
Optimized search queries tailored to product and drug class
Quality control checks to ensure completeness and accuracy
Structured reporting and full traceability for audit readiness
Seamless Integration with Your PV System
Our literature monitoring services are fully integrated into the pharmacovigilance framework, ensuring smooth data flow and consistency across all safety activities.
Our Pharmacovigilance Framework
Alignment with case processing and safety databases
Collaboration with medical writing and signal management teams
Continuous communication and reporting
Compliance with global Good Pharmacovigilance Practices (GVP)
Flexible Delivery Models Baupharma offers scalable solutions tailored to operational needs:
Fully Outsourced Mode
Full outsourcing of literature monitoring activities
Hybrid Model
Hybrid models integrated with internal PV teams
Targeted Support
Support for specific products, portfolios, or regions
Identify emerging safety signals early
Partner with us for reliable insights
Why Partner With Us ?Your Trusted Pharmacovigilance Partner
Global and local coverage with multilingual expertise
Scientifically trained teams with PV specialization
Strong regulatory compliance and inspection readiness
Tailored strategies aligned with product portfolio
Technology-driven processes for efficiency and accuracy
Turning Literature into Actionable Safety Insights
Baupharma goes beyond literature screening, transforming scientific publications into meaningful safety intelligence that supports compliance, strengthens risk management, and ultimately enhances patient safety.
Case Processing (ICSR Management)
Accurate Safety Data. Timely Reporting. Full Compliance.
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