Surveillance Schedule

Integrate signal detection and benefit risk schedules into a single interface for surveillance oversight

From signal to risk

Centralized oversight for surveillance across your product portfolio

Harmonizing signal detection and benefit-risk evaluation schedules with Orbit ensures a structured, repeatable process that enhances both efficiency and consistency across pharmacovigilance and regulatory teams.

By automating the scheduling of safety signal reviews, BRAT meetings, and benefit-risk assessments, Orbit eliminates manual tracking, reduces administrative burden, and ensures timely decision-making. This alignment not only streamlines regulatory compliance but also fosters cross-functional collaboration, ensuring that safety updates and risk assessments are systematically reviewed and communicated across the organization. With a unified approach, teams can proactively manage evolving risks while maintaining a clear, auditable record of benefit-risk decisions.

Consistency, effeciency, and oversight across the portfolio.

Strategize and execute safety signal detection and monitoring

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.

Benefit-Risk Action Teams, managed.

Ensure timely and compliant assessents with automatic scheduling of benefit-risk reviews, BRAT Meetings, and documentation so your team never misses a critical deadline.

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

Integrated Benefit-Risk

Add automation to your SOP's to deliver high quality decisions and process efficiency

Safety Surveillance Resources

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

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