Benefit-Risk Management
Managing benefit-risk strategies across a drug’s lifecycle can be complex, with evolving regulatory expectations, ongoing evaluations, and cross-functional collaboration challenges. Orbit ensures structured, efficient, and transparent benefit-risk management—so nothing falls through the cracks.
Structured Assessments
Take the mystery out of benefit-risk
With countless regulations, guidelines, and trendy frameworks to consider, benefit-risk management is anything but straightforward. And with an ever-increasing focus on the content of these evaluations, organizations are still left in the dark when it comes to defining their internal practices and procedures for managing this cumbersome process.
Orbit takes a new approach to helping you manage benefit-risk:
- Managing and scheduling Benefit-Risk Action Team (BRAT) meetings by product
- Managing benefit-risk documentation to give a complete history of benefit-risk decisions
- Connecting Benefit-Risk to other processes in PV, including Safety Surveillance and Risk Management
Simplify Schedules
Automate your benefit-risk action team schedule
Benefit-Risk Evaluations follow complex timelines, occurring both periodically and ad-hoc. Orbit helps manage this complex schedule for each product across your global organization.
By managing Benefit-risk schedules in Orbit alongside documentation, your team will gain instant insight into your organization’s knowledge and history across the portfolio.
Manage Benefit Risk Action Team (BRAT) membership, automatically schedule meetings and notify members
Manage meeting minutes, benefit-risk documentation (e.g. BRAD, BRSD, cSBRA, etc.) and other meeting output directly in Orbit.
Core Structured Benefit Risk Assessment
Create consistency across global benefit-risk
Orbit supports Core Structured Benefit-Risk Assessments (cSBRA), allowing teams to maintain a centralized benefit-risk stance and documentation– serving as a vital source for regulatory documents across global reports and submissions. Orbit helps teams schedule cSBRA maintenance and reviews throughout the clinical and post-marketing phases of drug development.
Reduce redundant benefit-risk work
Streamline local submissions
Prevent inconsistency
from the blog
Maximizing Consistency: The Power of a Benefit-Risk Strategy Document in Pharmaceutical Management
As pharmaceutical companies navigate the complex landscape of drug development, regulatory compliance, and patient safety, having a clear and comprehensive benefit-risk management strategy is essential. One powerful tool that can greatly enhance consistency and effectiveness in this arena is a Benefit-Risk Strategy Document. Let’s delve into how this document can serve as a guiding light for pharmaceutical benefit-risk management, fostering consistency, transparency, and informed decision-making.
Connected trackers
Safety Surveillance
Harmonize BRAT meetings and benefit-risk activities with each product’s signal periodicity
Document Exchange
Distribute periodic benefit-risk evaluations to global partners and affiliates
Learn how Orbit connects global safety
Schedule a call today.