Additional risk minimization measure (aRMM) tracking has specific compliance gaps that manual spreadsheets create, from ownership drift to no defensible audit trail. Here's how to close them.
Read More »July 27, 2026
Spreadsheets can track pharmacovigilance commitments, but they can't provide real oversight. Here's why spreadsheet-based PV tracking breaks down.
Read More »July 20, 2026
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 orga
Read More »May 28, 2026
We're proud to share that Orbit team members Kevin Fetterman and Christopher Long have co-authored a newly published article in Therapeutic Innovation & Regulatory Science.
Read More »July 1, 2025
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 a documentation exercise—it's a regulatory responsibility.
Read More »May 22, 2025
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 and missed signals.
Read More »April 8, 2025
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.
Read More »February 11, 2025
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 adverse drug events.
Read More »January 16, 2025
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 and submission of aggregate safety reports (ASRs) are essential for tracking a product's safety profile across different markets.
Read More »December 12, 2024
Signal management is a fundamental aspect of pharmacovigilance, helping pharmaceutical companies identify potential safety concerns and take swift action to mitigate risks.
Read More »October 7, 2024
Pharmacovigilance is rapidly evolving, driven by technological advancements that transform how pharmaceutical companies monitor, detect, and manage the risks associated with marketed products.
Read More »July 19, 2024
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 leads to inefficiencies, lengthy negotiations, and compliance risks.
Read More »March 16, 2024
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.
Read More »February 7, 2024
Explore how Orbit merges global risk management with local implementation, ensuring safety and compliance worldwide.
Read More »November 27, 2023
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.
Read More »May 30, 2023
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.
Read More »April 25, 2023
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.
Read More »March 30, 2023
Unlock the full potential of your team's implementation with Orbit.
Read More »March 10, 2023
Post-Conference takeaways from DIA Pharmacovigilance and Risk Management Strategies Conference 2023, Bethesda, MD.
Read More »February 21, 2023
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.
Read More »January 10, 2023
Orbit streamlines risk management by harmonizing core strategies with localized needs, ensuring effective and consistent implementation across all levels.
Read More »December 1, 2022
A year in Orbit 2022 - a recap of the past year and what to look forward to in the coming years.
Read More »November 10, 2022
Unlocking the complexity of Pharmacovigilance Agreements through five essential phases.
Read More »August 19, 2022
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.
Read More »June 28, 2022
The past two decades have seen a fundamental "swing of the pendulum" where regulatory agencies have increasingly scrutinized the patient safety risks associated with medications.
Read More »April 18, 2022
The regulatory demands of guidance, PV Legislation, and local Health Authority requests are ever-increasing. With that, so too is your global Aggregate Safety Reporting workload.
Read More »March 11, 2022
The pharmacovigilance industry is locked in a race toward ever-more complicated signal detection algorithms. Cutting-edge technology like artificial intelligence
Read More »July 13, 2021
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 ahead of their regulatory commitments for risk management.
Read More »June 17, 2021
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.
Read More »March 10, 2021
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 lessons learned.
Read More »January 19, 2021
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 More »December 8, 2020
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 supporting their pharmacovigilance services.
Read More »November 18, 2020
Drug Safety organizations are responsible for a variety of initiatives ranging from Health Authority required commitments to activities that keep operations running smoothly.
Read More »September 1, 2020
Safety Evaluations are central to Pharmacovigilance Sciences. Demonstrating consistency in retrieving data for analysis can pose a challenge for large, global and matrix organizations.
Read More »July 28, 2020
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 Meeting is scheduled to begin this weekend, with content streaming Sunday, June 14, through Thursday, June 18.
Read More »June 10, 2020
The successful handling of PVA obligations is a critical but often overlooked consideration.
Read More »May 25, 2020
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.
Read More »April 29, 2020
The new integration will support Patient Safety organizations as they define their safety data evaluation strategies
Read More »April 9, 2020
Dan Feith of Orbit recently co-presented a webinar with Carla Perdun Barrett of PRA Health Sciences. The webinar recording is available here.
Read More »February 13, 2020
Takeaways from the PV & Risk Management Strategies meeting
Read More »February 4, 2020
It's January, and that means we are gearing up for DIA's Annual Pharmacovigilance and Risk Management Strategies Conference (PVRMS).
Read More »January 16, 2020
Risk and Safety in the new decade will be all about scaling your processes for the long-term.
Read More »January 7, 2020
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 with a great software platform.
Read More »October 15, 2019
Over the years, a common question heard in consultations: "How do we track our distribution metrics for our aRMM's?"
Read More »August 2, 2019
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 procedural activities.
Read More »June 27, 2019
Our software may not be improving the lives of patients. But the people who use it are. Making medicines, therapies, & treatments to save or improve the lives of patients is no small endeavor.
Read More »June 21, 2019
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 shoes include capabilities like: – A no-training-necessary user interface – Simple Receiving, Archiving, and Sending of email
Read More »June 18, 2019
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). However, passive tools are inefficient.
Read More »March 1, 2019
Pharmaceutical companies encounter challenges with tracking and sharing CORE, EU, and Local implementation of their Risk Management Plans (RMPs).
Read More »February 15, 2019
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, and came back inspired.
Read More »February 13, 2019
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 clients to understand their current tracking efforts: the data input to the tracker to be replaced (usually a spreadsheet), the users responsible for updating the tracker, and the compliance metrics
Read More »December 3, 2018
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 aRMMs are notorious for creating challenges in operations and during inspections.
Read More »September 18, 2018
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 Report Generation and Submission, Safety Observations and Signals, Benefit Risk Evaluations, End-to-End Label Updates.
Read More »April 11, 2018
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 work to keep treatments safe and patients informed.
Read More »December 22, 2017
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 manual effort in pharmacovigilance.
Read More »July 25, 2017
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.
Read More »July 7, 2017
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 Eudravigilance Data Analysis System (EVDAS).
Read More »March 13, 2017
Keeping track of your various obligations and partnerships can be a chore. In this 20-minute webinar, the Orbit Team will go through three ways to simplify your PV Agreement tracking—from "quick wins" through end-to-end solutions.
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WEBINAR Aggregate Safety Reporting How to reduce global complexity with Orbit On-demand skip to registration Over the last few years, RIMS and Document Management
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WEBINAR MedDRA Query Strategies Safety Evaluations are central to Pharmacovigilance Sciences. Demonstrating consistency in retrieving data for analysis can pose
Read More »
