Automated Customised Multi-Template Narrative Generation

Need for this

Pharmacovigilance teams frequently face the challenge of preparing case narratives that meet diverse regulatory and partner-specific requirements. Each authority — such as EMA, USFDA, MHRA, APVMA, and others — specifies unique narrative formats, content fields, and structural expectations. 

Manual narrative writing and formatting consume significant reviewer time, introduce inconsistency, and increase the risk of human error. The complexity multiplies in multi-suspect drug cases, multiple adverse events, or follow-up submissions, where maintaining logical consistency and version control is essential. 

As case volumes grow, manual processes restrict scalability, delay reporting timelines, and complicate compliance. Regulatory audits further require full traceability of narrative versions, templates, and approval histories — making manual handling inefficient and audit-prone. 

How it Benefits

PvEdge addresses these challenges with Automated Customised Multi-Template Narrative Generation — a system-driven capability that transforms narrative creation into a fast, compliant, and scalable process. The system automatically populates narrative templates with structured and validated data, including patient information, drug details, events, and causality assessments. Rule-based logic ensures every narrative aligns with regulatory standards, maintaining consistent structure, tone, and completeness across all submissions. When a new authority, sponsor, or product requires a unique format, administrators can use PvEdge’s Template Builder to configure and deploy a new layout instantly — without requiring IT support.

How We Are Using This in Our Products

  • Data Auto-Population– Structured data from the safety database is mapped automatically into the relevant narrative template based on authority or sponsor requirements.
  • Template Flexibility – PvEdge supports multiple narrative configurations within a single PV system, ensuring tailored outputs for each regulatory or business need.

Template Type 

Purpose 

Example Output 

Regulatory Template 

For EMA/USFDA reporting 

Structured narrative for XML submission 

Sponsor-Specific Template 

For partner company reports 

Custom narrative per sponsor 

Product-Specific Template 

For product families (e.g., vaccines, vet drugs) 

Tailored content and rules 

Aggregate Report Template 

For PADER/PSUR inclusion 

Summarised narratives with consistent format 

  • Review & Approval Workflow – Quality Reviewer / PV Manager verifies compliance and finalises narratives.
    System Administrator manages template setup, access controls, and configuration.
  • Version Control & Traceability – Each narrative and template is version-controlled, with a full audit trail to support regulatory inspections and internal QA reviews.

Result of Implementation of PADER

As a service recipient PADER software can streamline pharmacovigilance process, improve report quality by automated data integration and standardized data templates, enhance drug safety monitoring efforts by regular and timely submission, reduce workload by automating repetitive tasks and provide timely reminders, no chance of missing any timeliness. 

Result of Implementation

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Automation & Efficiency

Reduces narrative preparation time by up to 70%.

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Standardisation

Maintains consistent formats and content across authorities and partners.

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Error Reduction

Reduces narrative preparation time by up to 70%.

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Flexibility & Scalability

Adapts easily to new reporting requirements without IT dependency.

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Audit Readiness

Ensures complete traceability of templates, changes, and approvals.

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System Integration

Links directly with E2B XMLs, aggregate reports (PADER/PSUR), and partner submissions.

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