UC-414
Adverse Event Intake and Signal Dossier
Reads inbound adverse event reports in any format, drafts case narrative and coding, and assembles evidence behind each candidate signal.
TBDBuild Duration
XXXXIndicative ROI
XXXXBuild Cost
XXXXValue
The Challenge
Case volume grows faster than headcount and every late or miscoded case is a regulatory finding. Reports arrive by mailbox, call centre, literature and partner feed, each in a different shape.
How It Works
- Reads the intake mailbox, call centre notes, literature abstracts and the safety database.
- De-duplicates cases, drafts coding and seriousness fields, and clusters events into signals.
- Every case and signal pack goes to the pharmacovigilance qualified person, who submits.
What It Removes
- Manual keying of case data into the safety database
- Duplicate case hunting across partner exchange files
- Hand-built line listings for the signal review meeting
Input Data RequirementsSafety database extracts, intake mailbox, call centre transcripts, literature screening output, partner exchange files, product labels
Output FormatDrafted case narratives with coding proposals, duplicate register, candidate signal packs with line listings and links to every source record
“We spend the clock re-typing the same report out of four inboxes, then rebuild the line listing by hand for the signal meeting”