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Case study · Healthcare

Safety case intake for a mid-sized generic drugmaker

Client

A mid-sized generic pharmaceutical manufacturer in India

Industry

Healthcare & Life Sciences

Solution families

Enterprise Integration and Automation · AI and Autonomous Operations

Time to proof

6 weeks

Executive summary

Adverse-event reports arrived by email, PDF and call notes, and safety associates keyed every one into the safety database by hand. An intake connector now turns each report into a structured safety case the same day, checked by an associate before it is saved.

Key outcomes

Same day

Structured case creation, down from 3 days

70%

Reduction in manual data entry per case

100%

Cases checked by a safety associate

Solution and architecture

What we composed.

Reports land in a safety inbox, where extraction identifies the patient, drug, event and seriousness and maps them to standard terminology. Safety associates review and complete each case, and approved cases are written to the safety database ready for reporting, with a full audit trail.

Data in

Safety inbox

Emails, PDFs and call notes

Intelligence

Extraction and coding

Patient, drug, event, seriousness

Workflow

Associate review

Checks and completes each case

Systems of record

Safety database

Structured cases, ready to report

Solutions Intelligence, applied.

Level 1

Sense

Measured case volumes, formats and the time each case took.

Level 2

Reason

Agreed which fields can be prepared and which an associate must confirm.

Level 3

Compose

Designed intake, extraction and review around the existing safety database.

Level 4

Prove

Validated on de-identified historical reports against agreed accuracy targets.

Level 5

Evolve

Added report sources and languages after go-live.

Technology

Document AIMedical terminologyLLM gatewayWorkflowAudit trailSafety database connector

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