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% less drafting effort
Cut PSUR drafting and template-population effort by up to 50% by generating first-pass sections from consolidated period evidence, prior PSUR content, and governed regulatory guidance.
Fewer review loops
Reduce cross-functional review loops by improving consistency across narratives, tables, safety updates, actions taken, and benefit-risk sections before PV and medical review.
Source-linked benefit-risk rationale
Support benefit-risk conclusions with source-linked evidence, change rationale, and a full run record across cases, signals, literature, aggregate analyses, RMP updates, and prior commitments.
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.
Human-in-the-loop PSUR co-authoring: PV and medical teams stay in control of drafting, edits, review decisions, and final sign-off while Biolevate accelerates structured section generation.
Guideline-governed benefit-risk drafting: PSUR sections are populated into approved templates using regulatory guidance, source-linked claims, and traceable rationale for inspection readiness.