Orbit Versus a Custom-Built Solution
In today’s fast-paced business environment, companies are constantly seeking ways to enhance their processes and
Author: Mary Coleman
Risk Minimization 360: Two cutting-edge technologies that re-shape the way you manage your risk
This article explores two cutting-edge platforms – Orbit and Axian One – that enable pharma and biotech companies to achieve a 360-degree view of their risk management activities.
From Reactive to Proactive: The Evolution of Aggregate Safety Reporting
Introduction Aggregate safety reporting is an essential component of drug safety, enabling the identification and
The Revolution of Technology in Pharma
Post-Conference takeaways from DIA Pharmacovigilance and Risk Management Strategies Conference 2023, Bethesda, MD Status Pharmacovigilance
Orbit 2023 – Kicking Off the New Year
A Decade In the Making As we celebrate our 10-year anniversary as a Software Solutions
Reaching Consensus on Core and Local Implementation
Companies are required to have and implement risk minimization measures, but there isn’t clear guidance on HOW to implement them beyond core documents like Risk Management Plans (RMPs). This article addresses the cross-functionalities of implementing risk minimization measures at multiple levels, and how Orbit can track variants and adaptations
The Process and Tracking “It” in Orbit
A year in Orbit – 2022 recap of the past year and what to look forward to in the coming years.
PVA Checklist – Five Phases
Importance of a PVA A Pharmacovigilance Agreement’s importance boils down to the shared activities between
Recap: Modernizing your PVAs with Orbit
Key take-aways from our June Webinar on modernizing your PVAs. Insights from presenters Katherine Long
RMP and REMS: The Most Stringent Risk Minimization Measures – Restricted Distribution
Background The past two decades have seen a fundamental “swing of the pendulum” where regulatory
