Pharmacovigilance using RoseRx
RoseRx screens every patient and HCP conversation and routes structured potential adverse event cases into your safety systems for review.
Working with RoseRx
Process ownership
RoseRx
Detection
Built in PV agents run at all times on all conversations for both patients and HCPs for scoring.
Screen and triage
All communication is reviewed by a vetted triage team daily to identify and complete a possible cases.
Your PV team
Receiving files
PV team receives the cases from RoseRx via an API to your systems or as structured data mapped to an E2B file.
Case filing
Causality, coding, and submission stay with the people accountable under your SOPs.
Data collection
What is captured
The triage team, alongside RoseRx agents, are trained to detect and capture the following items, per ICH E2A guidelines:
Identifiable patient
Initials, age, gender as a minimum
Identifiable reporter
The contact details of the person raising the case
Suspect product
The product believed involved
Adverse event
What happened to the patient
The process
How it works
01
Detection
Patients or HCPs describe what happened in their own words. RoseRx scores probability of all communication via PV criteria and context, ready to be screened by a triage team.
Detection process involves:
Live screening across every conversation
Keyword triggers, scored by context and the links to causation
All communication is stored structurally for easy review
All communication is securely linked to verified contact information, in the case of follow up
02
Screen
All communication is reviewed by a vetted triage team to identify and complete a possible case before handing off to your internal PV team.
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
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 delivers the case via API or structured files, with a real-time alert to the processor on duty, directly into your safety system of record:
Oracle Argus
ArisGlobal LifeSphere
Veeva Vault Safety
All files are structured against the ICSR fields to populate into an E2B file.
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.
