PSUR updates are recurring, high-stakes deliverables under strict timelines, requiring teams to consolidate new safety information and demonstrate ongoing benefit-risk evaluation.
Data and insights are scattered across sources (ICSRs, signal detection outputs, medical literature, risk management documents, previous PSURs), making consolidation, consistency, and traceability difficult.
Identifying what changed since the last reporting period - and updating only what is needed without missing critical impacts - is a major bottleneck.
4× faster PSUR change review
Accelerate PSUR update cycles by comparing the previous report with new-period evidence and producing a section-by-section change map for reviewer validation.
Fewer missed section impacts
Systematically compare cases, signals, literature, aggregate analyses, RMP updates, and prior commitments against the previous PSUR to detect impacted sections and required updates.
Audit-ready change rationale
Link every proposed update to its triggering source, impacted section, change rationale, and reviewer decision for inspection-ready traceability.
How it works
1
Ingest baseline + new evidence — load the previous PSUR and consolidate new-period sources: cases, signals, literature, analyses, RMP updates, and commitments.
2
Define the comparison scope — select the reporting interval, product, indication, regions, source types, and PSUR sections to review.
3
Generate the change map — compare prior content with new evidence to flag changed facts, impacted sections, outdated statements, and missing updates.
4
Review and apply updates — PV and medical teams validate proposed impacts and convert approved changes into source-linked PSUR updates.
Section-by-section change map: show what changed since the last reporting interval, which PSUR sections are impacted, and which sources support each update.
Update engine, not auto-authoring: focus on change detection, impact analysis, and traceable recommendations while PV and medical reviewers control final wording and sign-off.