Literature Surveillance
Standardized Tracking & Audit Readiness
Compliant Tracking Protocols
A highly standardized, robust tracking architecture records every phase of the literature lifecycle—from initial query execution to final review disposition—fully satisfying regulatory scrutiny.
Â
Instant Record Retrieval
All literature logs, search history data, screened abstracts, and reviewer decisions are archived within a centralized, structured system, allowing for rapid, frictionless data retrieval during regulatory inspections and audits.
Search Strategy & Alerts
Compliant Search Strategies
Search strings and strategies are meticulously designed by safety information specialists to align exactly with strict global regulatory expectations (such as EMA and FDA guidelines).
​
Standardized Search Frequencies
Literature execution routines run on optimized, standardized frequencies (e.g., weekly cycles) to guarantee uninterrupted compliance and zero gaps in reporting windows.
Â
Alert Triggers
Custom-configured safety triggers instantly flag potential ICSRs, special situations, or evolving safety profiles, routing them to the pharmacovigilance team for immediate evaluation.
Automated Screening & Global Coverage
Automated Screening
Advanced, automated ingestion tools drive the initial screening phases, instantly filtering high-volume publications to isolate relevant safety data and eliminate manual fatigue.
​
Comprehensive Database Indexing
Broad, unrestricted coverage across all mandatory medical and scientific literature databases (including Embase, MEDLINE/PubMed, and local journals) ensures no global or regional safety signals are missed.