In today’s fast-paced business environment, companies are constantly seeking ways to enhance their processes and improve team efficiency, and in doing so inevitably seek out technologies that enable them to do so. As technology plays a vital role in achieving these goals, organizations often face the decision of choosing between custom-made solutions or opt for
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 also an extremely resource intensive, complex, and never-ending exercise that requires significant coordination by various teams. Failing to deliver on these activities could have serious consequences for patients, pharmaceutical, and
Ensure a successful rollout with an optimized approach
Post-Conference takeaways from DIA Pharmacovigilance and Risk Management Strategies Conference 2023, Bethesda, MD Status Pharmacovigilance and drug safety have undergone significant changes in recent years due to technological advancements, increased regulatory scrutiny, and the growing demand for more efficient and effective monitoring of adverse events associated with pharmaceutical products. At the DIA Global Pharmacovigilance and
A Decade In the Making As we celebrate our 10-year anniversary as a Software Solutions Provider for Pharma and Biotech companies, we at Orbit are grateful and excited to reflect on our approach to helping some of the world’s most advanced companies manage their safety-related needs. The Orbit platform was built on Feith’sSuite of Core
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
A year in Orbit – 2022 recap of the past year and what to look forward to in the coming years.
Importance of a PVA A Pharmacovigilance Agreement’s importance boils down to the shared activities between two or more parties, which is defined in this legal document between the Marketing Authorization Holder (MAH) and a third party. The purpose of the agreement is for the MAH to access all the relevant information relating to PV activities
Key take-aways from our June Webinar on modernizing your PVAs. Insights from presenters Katherine Long and Kevin Fetterman on streamlining your PV Agreement process from versioning through implementation with total oversight throughout. A robust Pharmacovigilance Agreement can protect both sides of a business partnership from uncertainty, communication gaps, and compliance risks. In fact, the GVP
