
Maximizing Consistency: The Power of a Benefit-Risk Strategy Document in Pharmaceutical Management
As pharmaceutical companies navigate the complex landscape of drug development,
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.
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.
Ensure timely and compliant assessents with automatic scheduling of benefit-risk reviews, BRAT Meetings, and documentation so your team never misses a critical deadline.
Reliable access to your decisions, data, and compliance obligations.
Manage your signal detection process across platforms, tools, and stakeholders
Store evidence and meeting minutes from detection, validation and assessment centrally
Add automation to your SOP's to deliver high quality decisions and process efficiency
As pharmaceutical companies navigate the complex landscape of drug development,
WEBINAR Enabling a modernized signal management process with Orbit On
The pharmacovigilance industry is locked in a race toward ever-more
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