Scientific literature monitoring is a critical pharmacovigilance activity, but it is increasingly overwhelmed by volume, fragmented sources, and tight timelines for signal evaluation.
Teams must continuously detect potential safety signals, determine whether they are already known or novel, and assess their relevance against the product’s benefit–risk profile and existing safety documentation.
Doing this reliably requires exhaustive reading, consistent classification, and strong traceability — yet manual workflows make prioritization slow and difficult to scale across portfolios.
5× faster signal triage
Accelerate literature screening, extraction, and first-pass classification by up to 5× with product-aware signal registers and dossier confrontation.
2× more signals covered
Scale surveillance across more journals and products without adding headcount by applying standardized logic to high-volume literature streams.
Audit-ready traceability
Defend signal decisions with source-linked evidence, classification rationale, and a full run record — improving inspection readiness and cross-functional alignment.
How it works
1
Set up product-specific surveillance — define the product profile (substance, indications, populations, known risks) and the literature sources to monitor; Biolevate maintains a governed, versioned monitoring scope.
2
Extract signals from new scientific articles — continuously retrieve and screen publications, then extract candidate signals (events, populations, exposures, outcomes) into a structured signal register with source passages.
3
Confront each signal with the product dossier — compare extracted signals against your safety evidence base (e.g., prior assessments, labeling, RMP, PSUR history, known/expected risks) to classify: already known vs new, expected vs unexpected, severity, plausibility, and potential impact.
4
Prioritize and document next actions — generate a ranked queue (triage) with rationale and traceability, plus suggested follow-ups (deeper review, escalation, update to PSUR/RMP/label) supported by a full run record for audit and inspection readiness.
Signal-to-dossier linking: automatic confrontation of literature signals with your product safety documentation to speed up classification and reduce missed context.
Exhaustive, traceable reading: every extracted signal and decision rationale is linked to source passages with an auditable run record.