Literature monitoring with reviewer-confirmed identification
Schedule searches across the databases that matter, screen and triage results automatically, and let AI surface candidate ICSRs that a qualified reviewer confirms against ICH E2D criteria — before any case is ever created. Built for GVP Module VI literature obligations.
From thousands of hits to a handful of confirmed ICSRs
Recurring searches return far more than is reportable. PVgenix does the heavy lifting — deduplicating, triaging for relevance, and retrieving full text — so reviewers spend their time only on the articles that could be genuine individual case safety reports.
Recurring queries run against PubMed/MEDLINE, Embase, local and national journals on a configurable cadence — never a missed cycle.
AI screens titles and abstracts against your strategy, removing duplicates and previously-reviewed articles before a human looks.
Qualifying articles are pulled in full text with reviewer annotation, ready for structured ICSR identification.
AI surfaces candidates. A qualified reviewer confirms.
The AI proposes — it never decides. Every candidate ICSR is presented to a qualified reviewer with the evidence and the four ICH E2D validity criteria laid out. Only after a human confirms does an article become a structured case.
AI assists intake and data entry. Qualified personnel review, edit, and approve AI-generated content before a case proceeds; regulated judgments remain with the client's PV personnel.
Search string to sign-off, on one audit trail
Every article that enters the workflow carries its history with it — what search returned it, how it was screened, who reviewed it, and how it was dispositioned — so the full chain is inspection-ready.
Scheduled search
Recurring queries run against PubMed/MEDLINE, Embase, local and national journals on a set cadence.
PubMed · EmbaseDeduplication
Duplicate and previously-reviewed articles are dropped automatically so reviewers never see the same record twice.
previously reviewedScreening & triage
AI screens titles and abstracts for relevance against your strategy and routes in-scope articles forward.
AI triageFull-text review
Qualifying articles are retrieved in full text with reviewer annotation for a closer read.
full-textICSR identification
AI flags candidate ICSRs; a qualified reviewer confirms validity against the four ICH E2D criteria.
reviewer-confirmedArticle-to-case & sign-off
Confirmed articles convert to structured ICSRs with a generated source PDF and QPPV / safety-reviewer sign-off.
QPPV sign-offSearch strategy
Screening & deduplication
Sign-off chain
A defensible record, from search string to sign-off
Inspectors want to see not just the cases, but the reasoning. PVgenix captures the search strategy, every screening decision, and the reviewer and QPPV sign-off — a continuous, version-controlled chain of evidence for each article and each cycle.
Articles already assessed in earlier cycles are recognised and set aside, so effort is never duplicated.
Search strategy, screening calls and reviewer sign-off are time-stamped and attributable — inspection-ready by design.
Route confirmations through screener, safety reviewer and QPPV sign-off — configured to your SOPs.
This describes the platform's overall capability set, not a fixed shipped feature list; scope is defined per client agreement.
See reviewer-confirmed literature monitoring in action
Request a demo to see scheduled searches, automated screening, and AI-assisted ICSR identification confirmed by a qualified reviewer.