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Regulatory compliance

/ Signum

Signal Detection & Management

Find the signal. Validate it rigorously. Act before regulators ask.

Signum provides quantitative disproportionality analysis (PRR, ROR, EBGM) across your safety database — combined with a structured signal validation and lifecycle management workflow that satisfies ICH E2E and GVP Module IX from detection to closure.

Key capabilities

Disproportionality Analysis

Automated Signal Detection

Signal Prioritisation

Structured Validation Workflow

Risk Assessment Documentation

Historical Trending

PRR · ROR · EBGM

< 1h

Screening run time

ICH E2E

Lifecycle compliance

GVP Module IX

Assessment framework

What it does

All the capability, none of the complexity.

Signum provides quantitative disproportionality analysis (PRR, ROR, EBGM) across your safety database — combined with a structured signal validation and lifecycle management workflow that satisfies ICH E2E and GVP Module IX from detection to closure.

01 Disproportionality Analysis

PRR, ROR and EBGM computed on your ICSR database. Multi-drug, multi-event and subgroup analyses. Configurable thresholds per product and class.

02 Automated Signal Detection

Scheduled screening runs identify new disproportionalities and changes in existing signals. Delta reports highlight emerging vs established signals.

03 Signal Prioritisation

Composite priority scoring incorporating statistical strength, clinical severity, novelty vs SPC, literature evidence and regulatory environment.

04 Structured Validation Workflow

ICH E2E-aligned lifecycle: New → Under Assessment → Validated / Refuted → Closed. Each transition requires documented rationale and role-based approval.

05 Risk Assessment Documentation

Structured risk-benefit narrative with evidence sections — quantitative data, literature, clinical context, regulatory landscape — with AI assistance and human sign-off.

06 Historical Trending

Signal strength trends over time with configurable rolling windows. Early warning for gradual disproportionality growth before formal threshold crossing.

07 Multi-product & Class Analysis

Cross-drug analyses for class effects. Shared-substance signals flagged across the product portfolio with impact assessment per MA holder.

08 Regulatory Signal Reports

PRAC/PBRER signal management section content generated from the Signum signal record — no re-entry into separate documents.

How it works

From day one to every day after.

A typical journey through Signal Detection & Management — from onboarding to steady-state operations.

1

2

3

4 Data preparation

ICSR case database synchronised from Salvus ICSR. Reference dataset configured. Case exclusion rules applied per protocol.

Screening run

Statistical analyses produce a scored signal list. New disproportionalities and threshold crossings highlighted versus the previous run.

Validation

PV scientist reviews the signal, assembles evidence and documents the validation decision with full rationale and evidence file.

Action & reporting

Validated signals trigger RMP updates, regulatory communications or labelling assessments. Records feed PBRER and PRAC signal reports.

See It in Action

Watch Signal Detection & Management in action.

A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.

.

How to add your demo video

1. Upload the Signal Detection & Management demo to YouTube.

2. Copy the video ID from the URL — the part after watch?v=

3. In the HTML above, find: data-vid="PASTE_VIDEO_ID_HERE"

4. Replace PASTE_VIDEO_ID_HERE with your actual video ID.

5. Save & deploy — the play button handles the rest automatically.

Integrations

Connects where you need it to.

Signal Detection & Management is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

Regulatory compliance

/ Signum

Signal Detection & Management

Find the signal. Validate it rigorously. Act before regulators ask.

Signum provides quantitative disproportionality analysis (PRR, ROR, EBGM) across your safety database — combined with a structured signal validation and lifecycle management workflow that satisfies ICH E2E and GVP Module IX from detection to closure.

Key capabilities

Disproportionality Analysis

Automated Signal Detection

Signal Prioritisation

Structured Validation Workflow

Risk Assessment Documentation

Historical Trending

PRR · ROR · EBGM

< 1h

Screening run time

ICH E2E

Lifecycle compliance

GVP Module IX

Assessment framework

What it does

All the capability, none of the complexity.

Signum provides quantitative disproportionality analysis (PRR, ROR, EBGM) across your safety database — combined with a structured signal validation and lifecycle management workflow that satisfies ICH E2E and GVP Module IX from detection to closure.

01

Disproportionality Analysis

PRR, ROR and EBGM computed on your ICSR database. Multi-drug, multi-event and subgroup analyses. Configurable thresholds per product and class.

02

Automated Signal Detection

Scheduled screening runs identify new disproportionalities and changes in existing signals. Delta reports highlight emerging vs established signals.

03

Signal Prioritisation

Composite priority scoring incorporating statistical strength, clinical severity, novelty vs SPC, literature evidence and regulatory environment.

04

Structured Validation Workflow

ICH E2E-aligned lifecycle: New → Under Assessment → Validated / Refuted → Closed. Each transition requires documented rationale and role-based approval.

05

Risk Assessment Documentation

Structured risk-benefit narrative with evidence sections — quantitative data, literature, clinical context, regulatory landscape — with AI assistance and human sign-off.

06

Historical Trending

Signal strength trends over time with configurable rolling windows. Early warning for gradual disproportionality growth before formal threshold crossing.

07

Multi-product & Class Analysis

Cross-drug analyses for class effects. Shared-substance signals flagged across the product portfolio with impact assessment per MA holder.

08

Regulatory Signal Reports

PRAC/PBRER signal management section content generated from the Signum signal record — no re-entry into separate documents.

How it works

From day one to every day after.

A typical journey through Signal Detection & Management — from onboarding to steady-state operations.

1

2

3

4

Data preparation

ICSR case database synchronised from Salvus ICSR. Reference dataset configured. Case exclusion rules applied per protocol.

Screening run

Statistical analyses produce a scored signal list. New disproportionalities and threshold crossings highlighted versus the previous run.

Validation

PV scientist reviews the signal, assembles evidence and documents the validation decision with full rationale and evidence file.

Action & reporting

Validated signals trigger RMP updates, regulatory communications or labelling assessments. Records feed PBRER and PRAC signal reports.

See It in Action

Watch Signal Detection & Management in action.

A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.

.

How to add your demo video

Integrations

Connects where you need it to.

Signal Detection & Management is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

ICSR

Case database — source data for analysis

Crypta

Literature evidence for signal assessment

RMP

Validated signals update safety concerns

Reg Intelligence

HA signal queries and referral monitoring

Compliant with

ICH E2E

GVP Module IX (Rev 1)