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 updates
Accelerate PSUR cycles by automating consolidation, gap analysis, and guided rewriting from a structured evidence pack.
Fewer missed impacts
Exhaustively detect which statements and sections are affected by new safety information to reduce omissions and last-minute rework.
Audit-ready traceability
Maintain defensible updates with source-linked evidence and a full run record — supporting inspections and smoother internal sign-off.
How it works
1
Ingest the baseline PSUR + new evidence - load the previous PSUR and consolidate new inputs for the period (case narratives, aggregate analyses, signals, literature, actions, RMP changes) into a governed evidence pack.
2
Build the update context — define the reporting interval, product/indication scope, and target sections (e.g., signals, benefit–risk, actions) to structure the update plan.
3
Run an exhaustive gap & change analysis — compare the previous PSUR against new period evidence to detect impacted sections, outdated statements, missing updates, and required rewrites; produce a traceable change map (what changed, why, and which sources support it).
4
Generate guided updates & finalize - draft updated sections and tables directly in your PSUR template with source-linked claims and a run record, then review/approve with PV and medical teams.
Traceable gap analysis: section-by-section change detection with evidence-linked rationale and run records, reducing missed updates.
Evidence-linked drafting: grounded updates tied to underlying cases, literature, and analyses for audit and inspection readiness.