PSUR authoring is a recurring, high-stakes deliverable under strict regulatory timelines, requiring teams to consolidate new safety information and demonstrate ongoing benefit–risk evaluation.
Inputs are fragmented across sources (ICSRs, signal detection outputs, medical literature, actions taken, RMP updates, previous PSURs), making consolidation, consistency, and version control difficult.
Ensuring traceability of every conclusion and consistently applying regulatory guidance across cycles is a major bottleneck for PV and medical teams.
50% time reduction
Cut PSUR drafting effort by ~50% by automating template population from consolidated period evidence and governed guidelines.
Improved quality & consistency
Standardize narratives and tables across sections and cycles to reduce rework, deviations, and cross-functional review loops.
Exhaustive, audit-ready traceability
Defend benefit-risk conclusions with source-linked evidence and a full run record - improving inspection readiness and smoother sign-off.
How it works
1
Build your PSUR template in Biolevate - create a standardized structure (sections, tables, required fields) and attach writing rules and regulatory guidance that govern each part.
2
Ingest and structure period evidence - consolidate new inputs for the interval (cases, aggregate analyses, signals, literature, actions, RMP changes) alongside the previous PSUR to assemble a governed evidence pack.
3
Populate the template with traceable content - Biolevate drafts updated narratives and tables directly into your template, grounding each statement in the underlying evidence with a run record.
4
Review, refine, and reuse - PV and medical teams validate, edit, and finalize; then reuse the governed template + guidelines to accelerate the next cycle with consistent quality and auditability.
Run record guaranteeing exhaustive reading: every claim is source-linked with auditable traceability to support inspections and internal review.
Guideline-aligned generation: standardized outputs that consistently apply regulatory guidance while reducing manual rework.