Introduction As the pharmaceutical and technological landscape constantly evolves, staying agile and compliant is more crucial than ever. For small to mid-size pharma companies, this
Global Coordination, Local Implementation in Orbit: The Industry-Leading Solution for Managing and Tracking Risk Management Activities
Introduction When it comes to global risk management, pharmaceutical companies are in constant global/local tug-of-war – trying to achieve harmonization and consistency across efforts while
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.
Introduction Aggregate safety reporting is an essential component of drug safety, enabling the identification and management of safety concerns related to a product. It is
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