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AI-Assisted PSUR Drafting — Inside Microsoft Word

Generate structured first drafts of Periodic Safety Update Reports from safety data and historical reports in 60 minutes, with full traceability.

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Asthra AI automates Periodic Safety Update Report (PSUR) drafting by synthesizing safety evidence from multiple sources — including historical PSURs, Core Data Sheets, exposure data, and safety line-listings — into structured regulatory narratives with full traceability, inside Microsoft Word.

Who This Is For

Safety & Pharmacovigilance Writers

Pharmaceutical and biotech companies managing ongoing safety surveillance and periodic reporting obligations.

CRO Safety Delivery Teams

Contract research organizations and safety vendors delivering PSURs, DSURs, and PBRERs to sponsors on aggressive schedules.

The Complexity of PSUR Authoring

Six critical challenges that extend timelines and limit portfolio scale

Fragmented safety information across systems

Critical safety inputs are distributed across safety databases, quality management systems, complaint logs, literature repositories, and lab systems. Extensive manual effort required to extract, validate, and align all relevant data.

Time-intensive evidence review and narrative construction

Significant proportion of effort spent reading sources, distilling findings, and translating data into regulatory narratives. This limits time available for clinical interpretation and risk assessment.

Inconsistent structure and writing quality

Template differences, varying analytical depth, and inconsistent tone across PSURs lead to quality variability. Increased review comments and rework delays regulatory submissions.

Weak linkage between source data and final content

Authors lack auditable connection between safety data and written conclusions. Back-tracking for reviewer or regulatory queries is time-consuming and error-prone.

Under-utilization of prior knowledge and precedent

Information from earlier PSURs, Clinical Evaluation Reports, and vigilance reports not easily reusable. Authors repeatedly scan past documents instead of leveraging established precedent.

High error risk from manual repetitive work

Copying tables, updating figures, reformatting data, managing references, and maintaining consistency across multiple sections increases likelihood of transcription errors and inconsistencies.

How Asthra Supports PSUR Drafting

Unify safety data, synthesize evidence, and generate regulatory narratives

1

Unified ingestion of safety evidence

Asthra ingests previous PSURs, Core Data Sheets, safety line-listings, exposure datasets, sales data, and other safety inputs from multiple formats and systems.

2

Evidence synthesis and cross-source consistency

Asthra synthesizes safety evidence across sources into coherent narratives. Trend analysis is consistent across reporting periods and clinical interpretation is grounded in actual data.

3

Word-native, compliant authoring experience

Writers review and edit the PSUR first draft directly in Microsoft Word. Full version control, track changes, and audit trail of edits are maintained throughout the approval workflow.

4

Reuse of historical knowledge and precedent

Asthra leverages prior PSURs and cumulative safety knowledge, reducing duplication and ensuring consistency with past submissions and regulatory feedback.

5

Governed, auditable workflow

All content generation is traceable to source documents. Each statement is linked to data. Full audit trail from input through final submission.

The PSUR Drafting Workflow

Four stages from setup to regulatory-ready submission

1

Template Setup

Import PSUR template (standard ICH-based or customer custom). Asthra team configures prompts aligned to your regulatory requirements and SOP.

2

Ingest Safety Data

Upload Previous PSUR, Core Data Sheet, Exposure data, Sales data, Line-listings, and other safety inputs. Can be from local machine or Document Management System.

3

Generate & Synthesize

Click prompts to generate narrative sections synthesizing evidence across sources. Zero configuration needed. Review provenance and citations. Initial draft in 60 minutes.

4

Review, Refine & Submit

Expert review and medical interpretation in Word. Edit, correct provenance, validate evidence links. Complete audit trail for regulatory assessment.

Safety-Grade Evidence & Traceability

Maintain pharmacovigilance standards with every PSUR

Data Boundary Control

Asthra uses only the safety data and documents you provide. No external knowledge. No fabrication. Complete isolation of your confidential safety information.

Multi-Source Evidence Synthesis

Harmonizes safety information from disparate sources into coherent narratives while maintaining full visibility into where each statement originates.

Comprehensive Traceability

Every statement in the PSUR is linked to source documents or data tables. Sentence-level citations with file reference and location for full audit compliance.

Consistency Across Reporting Periods

Reuses prior PSUR content and knowledge to maintain consistency with previous submissions. Clearly marks new, changed, and ongoing safety signals.

What Asthra Can Help With

Asthra Excels At

  • •Compiling information from different safety sources into tables
  • •Summarization and evidence synthesis
  • •Trend analysis across reporting periods
  • •Generating consistent narrative from disparate sources
  • •Reusing prior PSUR content and structure

Out of Scope

  • •Complex calculations or statistical analysis
  • •Manipulating very large tables
  • •Medical judgment or safety conclusions
  • •Regulatory decision-making

PSUR-Specific Questions

Asthra generates 100% of the initial draft including structured summaries, safety trend discussions, exposure analysis, and consistent narrative synthesis. Clinical interpretation and benefit-risk conclusions remain under expert human review, ensuring medical judgment is preserved.
Asthra uses only provided source documents and datasets—never accesses external knowledge. When information is incomplete or ambiguous, Asthra explicitly flags it rather than inferring or fabricating data. This ensures safety narratives remain grounded in actual evidence.
Each statement in the drafted PSUR is linked to source documents, specific sections, or tables with sentence-level citations including file name and location. Reviewers can efficiently verify content during internal review and regulatory assessment.
Yes. Asthra supports iterative drafting by reusing prior PSURs and updating with new safety inputs. It maintains consistency across reporting periods while highlighting what is new, changed, or ongoing from previous submissions.
No. Asthra is designed to accelerate initial drafting and improve consistency. Human oversight is mandatory—experienced medical writers and safety officers must review and validate all outputs before submission.
Asthra explicitly highlights gaps and provides placeholders when data is incomplete. Writers can then source additional information or manually draft sections as needed. Asthra never assumes or extrapolates beyond provided evidence.
Asthra can be configured for Periodic Safety Reports (PSURs) across regulatory contexts, including pharmaceuticals, biologics, and medical devices. Specific applicability and configuration details are assessed during the pilot phase.
Teams experience 60%+ faster first-draft generation, improved consistency across PSURs, and reduced review effort due to built-in traceability. This accelerates the pathway to regulatory submission and supports larger safety portfolios.

See Asthra Draft a PSUR

Request a personalized demo to see how Asthra synthesizes your safety data into a regulatory-ready PSUR first draft.

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