Signal Management
Module IX compliant, inspection ready workflows and tracking for end-to-end Safety Surveillance and Signal Management

Holistic signal management
Track your surveillance activities beyond detection and resolution.
Despite advances in automated detection technology, safety teams continue to use outdated and manual tools for the rest of their workload. This puts them at risk of missed deadlines, reduced quality and overlooked data.
Orbit takes a different approach to signal management:
- Supporting all parts of the safety surveillance process
- Centralizing oversight and access to past decisions
- Collaborating with other PV functions
Orbit works in parallel with your detection system to add automation, workflow support and compliance to your end-to-end process.

Signal Tracking
Proven workflow for signal evaluation.

Manage the flow of all activities and data around detected signals, including analysis, prioritization and validation. Orbit helps you and your team track potential and validated signals from detection through resolution and closure.
- Module IX framework provides the structure your team needs to stay compliant with global regulations
- Flexible configuration options tailor the system to your organization's unique practices and procedures
- Evaluation timelines and tasks driven by signal priority
- Track signal actions with reminders and timelines
Detection strategy
A validated tool for safety surveillance strategy.
Orbit helps you define your signal detection strategy for each product. Make key signaling stakeholders, partners and data sources available at-a-glance. One location stores all source information, helping your team execute your Safety Surveillance Strategy on time and with a full, reportable, audit trail.
01
Create product detection strategy
02
Execute recurring surveillance activities
03
Track evidence, outcomes, and decisions

Your hub for safety surveillance.
Reliable access to your decisions, data, and compliance obligations.
Detection system agnostic
Manage your signal detection process across platforms, tools, and stakeholders
A complete history of evidence and decisions
Store evidence and meeting minutes from detection, validation and assessment centrally
Proactive and strategic management
Add automation to your SOP's to deliver high quality decisions and process efficiency
Signal Management on the Orbit Blog

The Future of Signal Management: How Process Automation is Shaping the Pharmacovigilance Landscape
Signal management is a fundamental aspect of pharmacovigilance, helping pharmaceutical

When Signal Management is the Answer to Signal Detection Challenges
The pharmacovigilance industry is locked in a race toward ever-more

Build-vs-Buy: How implementing a pre-configured PV Tracking solution will get you there faster
Most Pharma companies rely on passive tools—such as spreadsheets and
Signal Management Webinars

Enabling a modernized signal management process with Orbit
WEBINAR Enabling a modernized signal management process with Orbit On

Webinar: The Digital Transformation Toolkit for Global Patient Safety
WEBINAR The Digital Transformation Toolkit for Global Patient Safety On-demand

Webinar: Managing Safety Signals in Orbit
WEBINAR Signal Management with Orbit Safety Signals are the driving
Connected trackers
Document Exchange

Notify local partners and affiliates of newly detected or validated safety signals.
Read more →Safety Commitments

Track Safety Commitments and Health Authority Requests across Regulatory and PV functions.
See the webinar →Areas for Close Monitoring

With integrated MedDRA browsing, manage lists of structured query strategis.
Read more →Module IX ready with instant insight into signal detection and verification activities.
Schedule a call today.