Across global biopharma organizations, additional Risk Minimisation Measures (aRMMs) represent some of the most compliance-critical obligations a pharmacovigilance team manages. And yet, for many organizations,
New Publication: Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight We’re proud to share that Orbit team members Kevin Fetterman and
Why QPPVs and global PV leads need better analytics—and how to get them. For pharmacovigilance leaders, managing the Pharmacovigilance System Master File (PSMF) isn’t just
In the complex world of pharmaceutical drug safety, access to the right information at the right time can mean the difference between proactive risk 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.
In the pharmaceutical industry, ensuring patient safety is non-negotiable. Pharmacovigilance Agreements (PVAs) play a critical role in defining responsibilities between partners for monitoring and reporting
Pharmacovigilance is a critical part of ensuring patient safety and regulatory compliance in the pharmaceutical industry. Among the many responsibilities involved in pharmacovigilance, the creation
Signal management is a fundamental aspect of pharmacovigilance, helping pharmaceutical companies identify potential safety concerns and take swift action to mitigate risks. With the regulatory
Pharmacovigilance is rapidly evolving, driven by technological advancements that transform how pharmaceutical companies monitor, detect, and manage the risks associated with marketed products. The adoption
Pharmacovigilance Agreements (PVAs) are essential tools in ensuring drug safety and compliance across partnerships in the pharmaceutical industry. However, the complexity of these agreements often
Orbit Cloud introduces a game-changing solution for small to mid-size pharma and biotech firms, balancing efficiency with budget-friendly pay-per-user licensing.
Explore how Orbit merges global risk management with local implementation, ensuring safety and compliance worldwide.
Choosing the right tech solution can make or break a company’s efficiency and compliance in Pharma and Biotech industries. See how a cost-effective alternative to custom solutions is possible in Orbit.
Explore 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.
The adoption of electronic reporting systems, increased collaboration between stakeholders, and changes in regulatory requirements have all contributed to this shift in proactive safety reporting.
Unlock the full potential of your team’s implementation with Orbit.
Post-Conference takeaways from DIA Pharmacovigilance and Risk Management Strategies Conference 2023, Bethesda, MD.
Celebrating a decade of innovation, our mission continues to empower global safety teams with advanced, purpose-built solutions, freeing them from the manual and fragmented processes of the past.
Orbit streamlines risk management by harmonizing core strategies with localized needs, ensuring effective and consistent implementation across all levels.
A year in Orbit 2022 – a recap of the past year and what to look forward to in the coming years.
Unlocking the complexity of Pharmacovigilance Agreements through five essential phases.
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
Background The past two decades have seen a fundamental “swing of the pendulum” where regulatory agencies have increasingly scrutinized the patient safety risks associated with
The Challenge The regulatory demands of guidance, PV Legislation, and local Health Authority requests are ever-increasing. With that, so too is your global Aggregate Safety
The pharmacovigilance industry is locked in a race toward ever-more complicated signal detection algorithms. Cutting-edge technology like artificial intelligence, machine learning, and Big Data analytics
In a recent Orbit webinar, I was joined by Dr. Simon Ingate of Axian Consulting to discuss the ever-increasing compliance challenges companies face to stay
Our latest release included over 250 new features and improvements. The biggest driving factor this past year – for version 6 – was streamlining the system for local safety officers.
At a roundtable we recently facilitated on the topic of managing PV partners and associated agreements, we discussed with industry experts the best practices and
The distributed nature of aRMMs is a key challenge to implementation: it requires having a cohesive strategy and plan for implementing local RM activities. As was quickly pointed out, the effectiveness of RM programs is dependent on how well the programs are implemented at the local country level.
Read PRA Health Sciences’ quarterly newsletter here: Pharmacovigilance Newsletter The Feith Systems and PRA Health Sciences partnership delivers efficient tracking solutions to PRA’s clientele while
Drug Safety organizations are responsible for a variety of initiatives ranging from Health Authority required commitments to activities that keep operations running smoothly.
Safety Evaluations are central to Pharmacovigilance Sciences. Demonstrating consistency in retrieving data for analysis can pose a challenge for large, global and matrix organizations. This
DIA Global has been moved to a virtual platform this year, for the first time ever, due to the COVID-19 pandemic. The DIA Annual Global
The successful handling of PVA obligations is a critical but often overlooked consideration.
From evaluating effectiveness to tracking global implementation status, and rooting out non-compliance with SOPs at your favorite affiliate, collecting data has become a necessity for Tracking Systems.
The new integration will support Patient Safety organizations as they define their safety data evaluation strategies
Dan Feith of Orbit recently co-presented a webinar with Carla Perdun Barrett of PRA Health Sciences. The webinar recording is available here. The webinar abstract
Takeaways from the PV & Risk Management Strategies meeting
It’s January, and that means we are gearing up for DIA’s Annual Pharmacovigilance and Risk Management Strategies Conference (PVRMS). We set aside time to review
Risk and Safety in the new decade will be all about scaling your processes for the long-term.
Top subjects at Orbit Summit 2019 Orbit customers have two things in common—a dedication to improving patient safety processes and the vision to do it
Over the years, a common question heard in consultations: “How do we track our distribution metrics for our aRMM’s?“ Many organizations continue to rely on
Reflecting back on the busy week with the Feith Team reaffirmed how valuable Orbit software is in solving the ongoing challenges in tracking Pharma’s complex
Our software may not be improving the lives of patients. But the people who use it are. Making medicines, therapies, & treatments to save or
Email intake software for Adverse Events has big shoes to fill. It’s replacing Outlook, one of the most mature products of all time. Those big
Most Pharma companies rely on passive tools—such as spreadsheets and email—for tracking and managing their Risk Management Plans (RMPs) and Additional Risk Minimization Measures (ARMMs).
Pharmaceutical companies encounter challenges with tracking and sharing CORE, EU, and Local implementation of their Risk Management Plans (RMPs). Orbit makes tracking RMPs easy, while
Over the past few weeks, at DIA PVRMS in Washington DC and DIA Europe in Vienna, we had a lot of exciting and interesting conversations,
It’s not how much you CAN track, it’s how little you NEED to track At the beginning of each new project we work with our
Additional Risk Minimization Measures are invaluable for mitigating drug-related risks that are both severe and preventable. Having aRMMs in place often improves patient outcomes, yet
Feith introduces Orbit, a new platform that’s flexible, validated and intuitive. Perfect for Tracking: · Risk Management Plans, Commitments and Additional Risk Minimization Measures · Aggregate
Happy New Year to Patient Safety and Regulatory Professionals. You are responsible for massive amounts of data, and the stakes are high—yet every day you
Across the board, Pharmaceutical companies are looking to reduce the amount of effort they put into case processing. Case processing comprises a huge amount of
Modules V and XVI are closely related regulations providing requirements for Risk Minimization Measures (RMMs) that you’ll need to account for in your RMPs. Where
So you found a potential safety signal in Eudravigilance EVDAS… now what? The EMA introduced and made available (to MAH’s and national competent authorities) the
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