How ASR generation works
A transparent view of the data sources, agents, and report assembly steps used to generate your Annual Summary Report.
Generation pipeline
Start ASR wizard1
Input and validation
Capture drug identifiers, reporting period, and optional monograph upload.
2
Drug information extraction
Resolve drug metadata, mechanism, and indications from trusted sources.
3
Case and literature retrieval
Pull Canada Vigilance cases and literature references for the period.
4
Regulatory monitoring
Check Health Canada and other sources for relevant safety advisories.
5
Appendix assembly
Generate case histories, line listings, tabulations, and counts.
6
Section drafting
Draft Sections 1-9 with bilingual placeholders and required tables.
7
Quality checks
Validate inputs, flag missing data, and record audit metadata.
8
DOCX export
Assemble the report into a Word document with a placeholder theme.
Inputs and sources
Drug identifiers and metadata
DIN, INN, brand names, mechanism, indications, and manufacturer data.
Product monograph
Uploaded monograph used for extraction and change detection.
Canada Vigilance
Adverse event cases and counts for the reporting period.
Literature references
PubMed and curated sources for relevant publications.
Patient exposure
Sales and DDD inputs to compute patient-days.
Internal sources
Manufacturer-only safety data and internal case systems.
Generated outputs
Main report Sections 1-9
Bilingual section drafts with structured summaries.
Appendices 1-7
Safety advisories, monograph, case history tables, and counts.
DOCX/PDF exports
Approximate Word output ready for editorial review.
Audit metadata
Sources, timestamps, and validation flags for compliance.
Quality and review
Every report is generated with clear sources and review checkpoints.
Section validation
Checks for missing required inputs and placeholders.
Citations and provenance
Each section keeps a record of its sources.
Human review
Editorial review before final submission.
Bilingual output
English and French content are generated side by side.
Ready to generate a report?