Signals you can defend.
Detection, prioritisation, evaluation and the Signal Evaluation Report — on reproducible statistics, not spreadsheets.
PV physicians, signal scientists, QPPVs and quality reviewers.
Detect. Prioritise. Evaluate. Document.
One login with the rest of HAROM OnePV.
Every action audited
Role-based access · controlled workflows
- 1Detect
- 2Prioritise
- 3Evaluate
- 4Document
SignalIQ, as your team sees it.
An illustrative view of your workspace.
Detect. Prioritise. Evaluate. Document.
Signals · drug–event
Prioritised- Suspect product · MedDRA PTNew
- Suspect product · MedDRA PTUnder evaluation
- Suspect product · MedDRA PTDocumented
Evidence
- Literature screenedRecorded
- FAERS · eRMRLoaded
What SignalIQ does
Detect on your own data
MedDRA grouping at PT, HLT, HLGT and SMQ.
Statistics that reproduce
PRR, ROR, chi-square, EBGM/EB05, IC/IC025 — with subgroups.
External evidence, built in
FAERS public data and EudraVigilance eRMR exports.
Regulator registers, linked
EMA PRAC, FDA, MHRA, WHO UMC VigiAccess, Health Canada, TGA, PMDA.
Literature first
Structured screening with every decision recorded.
Owned, tracked, handed off
Signal lifecycle with a personal work queue.
SER in one click
GVP Module IX and CIOMS VIII structure, Word or PDF.
People decide. Systems record.
AI-assisted drafting and literature screening — switched on per client, always triggered by a reviewer, with every decision and every calculation owned by qualified PV professionals.
Standards and formats
Role-based access
Everyone sees exactly what their role allows.
Audit trail on every action
Who, what and when — always on record.
MFA or one-time code, enforced
Every sign-in verified twice.
Strict password policy
Strong, rotated, enforced.
Controlled workflows
Nothing skips a step.
Designed to support 21 CFR Part 11 and EU Annex 11 controls.
Same data, same result — every value traceable.
An audit trail your auditor can verify inside the application.
See it working
See SignalIQ in a live walkthrough with a HAROM PV expert.