Pharmacovigilance detection
RoseRx screens every patient and HCP conversation in real time and routes potential adverse events into your existing safety system within 24 hours.
Working within your protocol
Detection and hand off
RoseRx detection
People describe what happened in their own words. RoseRx scores the context to tell a report from a question.
Live screening across every conversation
Keyword triggers, scored by natural language context and the causation link
Human-in-the-loop
All conversations are
Your PV team's process
RoseRx sends a structured file XXX
Causality, coding, and submission stay with the people accountable under your SOPs.
PV team recieves
Causality and MedDRA coding
Seriousness calls and FDA submission
RoseRx detection
What our agents capture
RoseRx agents are trained to detect and capture four items, following ICH E2A. A human-in-the-loop process completes follow up for partially reported cases.
Identifiable patient
Initials, age, or gender is enough
Identifiable reporter
The person raising the case
Suspect product
The product believed involved
Adverse event
What happened to the patient
The process
How it works
01
Screen
All conversations are screened for the following criteria:
Adverse events
Product quality
Pregnancy exposure
Medication errors
Overdose
Misuse
Off-label use
Lack of efficacy / product not working
Counterfeit product
Any unexpected benefit
02
Capture
Captured against the ICSR fields your team validates:
Reporter
Patient
Product and dose
Event detail
03
Triage
Every screened case is triaged by a human before routing. Our operating standard is to get any potential AE into your PV queue within 24 hours of the conversation.
Partial capture cases:
Structured with a clear label of what is missing for easy reconciliation. Every conversation captures contact details to allow for follow up.
Duplicate cases:
Each case is assigned a unique ID and is checked against existing reports before routing for delivery to your systems.
04
Delivery
RoseRx submits via API or E2B file, with an alert to the processor on duty, into your system:
Oracle Argus
ArisGlobal LifeSphere
Veeva Vault Safety
05
Case filing
Causality assessment, MedDRA coding, seriousness and expectedness determination, and the FAERS submission run through your PV team's judgment, under your SOPs. RoseRx doesn't assess causality and doesn't file on your behalf.
06
Audit trail/Human review
Every conversation, consent record, and routing decision is logged, with an immediate escalation path to a human whenever the situation calls for it.
