Literature Monitoring

Overview

Scientific and medical literature is an important source of pharmacovigilance information. Published articles may contain Individual Case Safety Reports, new adverse reactions, changes in frequency or severity, special-population risks, medication errors, misuse, off-label use, or other information relevant to product safety.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders, pharmaceutical companies, CROs, and other life-sciences organizations with systematic local and global literature monitoring, article assessment, case identification, documentation, tracking, and escalation of relevant safety information.

Our approach focuses on consistent search strategy, documented screening, case-validity assessment, traceability, timely escalation, and integration of literature findings into wider pharmacovigilance activities.

Our Literature Monitoring Services

Literature Search Strategy

Development of product-specific search strategies using active ingredients, product names, synonyms, safety terms, and other relevant search concepts.

Local Literature Monitoring

Periodic review of applicable local scientific and medical literature sources to identify safety information relevant to marketed products.

Global Literature Screening

Support for screening international medical and scientific literature where required by the client’s pharmacovigilance scope.

Abstract Screening

Review of titles and abstracts to determine whether an article contains potentially relevant safety information requiring further assessment.

Full-Text Assessment

Detailed review of selected publications to determine reportability, case validity, relevance, and pharmacovigilance significance.

Literature ICSR Identification

Assessment of published case information to determine whether minimum criteria for an Individual Case Safety Report are available.

Duplicate Assessment

Review of available information to help identify potential duplicate literature cases or duplicate reports from other sources.

Safety Information Assessment

Identification of information related to:

• New adverse reactions
• Changes in known risks
• Serious adverse events
• Special populations
• Pregnancy and breastfeeding
• Medication errors
• Overdose
• Misuse and abuse
• Off-label use
• Lack of efficacy, where relevant
• Drug interactions
• Product-specific emerging safety concerns

Article Tracking & Documentation

Maintenance of literature-search records, screening decisions, assessment rationale, full-text status, case numbers, and associated comments.

Escalation & Case Processing Support

Timely transfer of valid or potentially reportable literature cases into the ICSR workflow for further processing, medical review, and regulatory reporting.

Signal & Aggregate Reporting Support

Identification and documentation of literature findings that may contribute to signal evaluation, aggregate reports, benefit-risk assessment, or risk-management activities.

Literature Sources We Can Support

Depending on scope, MGS may support searches across:

• PubMed / MEDLINE
• National and regional journals
• Scientific publications
• Medical journals
• Conference literature, where applicable
• Product-specific literature sources
• Local-language publications
• Other client-defined scientific databases and sources

Key Literature Assessment Considerations

MGS may evaluate:

• Product relevance
• Active ingredient
• Patient identifiability
• Reporter identifiability
• Adverse event
• Suspect product
• Case validity
• Seriousness
• Article type
• Duplicate potential
• Country of occurrence
• Special situation
• Clinical relevance
• Full-text availability
• Reportability
• Signal relevance
• Aggregate-report relevance
• Follow-up requirements
• Assessment rationale

Our Literature Monitoring Approach

• Define

Establish products, molecules, search terms, databases, countries, frequency, and reporting responsibilities.

• Search

Perform documented literature searches using approved search strategies.

• Screen

Review titles and abstracts to identify potentially relevant publications.

• Assess

Evaluate selected articles in greater detail and determine PV relevance, case validity, and reporting requirements.

• Escalate

Transfer reportable or clinically relevant information into the appropriate case-processing, signal, or aggregate-reporting workflow.

• Document & Track

Maintain searchable records of searches, screening decisions, rationale, case references, and completion status.

Typical Deliverables

Depending on scope, MGS can provide:

• Literature search strategy
• Search strings
• Literature search log
• Search-date records
• Abstract-screening records
• Inclusion / exclusion assessment
• Full-text assessment
• Literature case identification
• Duplicate assessment
• Assessment rationale
• Case reference tracking
• Full-text availability tracking
• Signal-relevant literature summary
• Aggregate-report literature support
• Literature compliance tracker
• Periodic literature reports

Why Choose MGS

Structured & Traceable Screening

MGS maintains clear documentation of what was searched, what was reviewed, and why an article was included or excluded.

PV-Focused Assessment

Literature is assessed from both scientific and regulatory pharmacovigilance perspectives.

Case & Signal Integration

Relevant publications can be linked directly to ICSR processing, signal management, aggregate reporting, and risk-management activities.

Flexible Search Scope

Support can be tailored to local literature, global literature, specific products, selected molecules, or client-defined portfolios.

Quality-Focused Documentation

Our approach emphasizes consistent screening decisions, documented rationale, timelines, and retrievable records.

Who We Support

MGS can provide Literature Monitoring support for:

• Marketing Authorization Holders
• Pharmaceutical companies
• Biopharmaceutical organizations
• CROs
• Generic-drug companies
• Product-license partners
• Organizations establishing literature-surveillance programs
• Companies requiring local or global PV literature support