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Despite advances in automated detection technology, safety teams continue to use outdated and manual tools for the rest of their workload.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.

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.


Create product detection strategy


Execute recurring surveillance activities


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 Resources

Connected trackers

Document Exchange

Notify local partners and affiliates of newly detected or validated safety signals.

Safety Commitments

Track Safety Commitments and Health Authority Requests across Regulatory and PV functions.

Areas for Close Monitoring

With integrated MedDRA browsing, manage lists of  structured query strategis.

Module IX ready with instant insight into signal detection and verification activities.

Schedule a call today.