Case studies / Signal management
Illustrative case study · Signal management
Bringing signal detection, evidence and decisions into one record
How a biotech company used vGenix Ai signal management, from baseline to results.
OrganisationBiotech company
RegionEU and US
Portfolio40 marketed products
ScopeSignal management
Results at a glance
What changed
Quarterly → monthlyDetection frequencyYour thresholds per product
100%Signals linked to evidenceBy design
100%Evaluations recordedBy design
ContinuousData to first reviewAs per clients SOP
The challenge
Where they started
- Signal detection run quarterly from spreadsheets
- Evidence gathered by hand for every potential signal
- Decisions recorded in meeting minutes
- Signal sections of PBRERs rebuilt each cycle
The solution
What they deployed
- Monthly disproportionality analysis with thresholds from SOPs
- Cluster analysis to find patterns across related terms
- Supporting cases and literature linked automatically
- Signal log feeding aggregate reports directly
Implementation
How it was rolled out
Month 1
Scope and methods
Methods, thresholds and workflow agreed from SOPs.
Month 2
Configure and validate
Detection and workflow configured and tested.
Month 3
Parallel cycle
One detection cycle run alongside the old process.
Month 4 onward
Steady state
Monthly detection and committee reviews on the platform.
Before and after
Measured against the agreed baseline
| Measure | Before (baseline) | After |
|---|---|---|
| Detection frequency | Quarterly | Monthly |
| Evidence gathering per signal | 10 hours | Few minutes |
| Decisions with recorded rationale | Partial | All |
| PBRER signal section preparation | Few days | Few hours |
Illustrative figures. In a real engagement, baselines are agreed before go-live and results measured from platform data.
Next step
Get results like these on your data
We agree the baseline with you, run a pilot on your own data, and report the results.
Recommended
6-week pilot on literature monitoring
- Baselines agreed up front
- Configured to your SOPs
- Measured on your own data
- Validation evidence from day one