Why Spreadsheet-Based PV Oversight Breaks Down
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
The Orbit Blog
Managing aRMM Implementation Across Affiliate Networks: Closing the Visibility Gap
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
Orbit Team Contributes to New Publication on Advancing Pharmacovigilance Practices
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
From Blind Spots to Full Visibility: Rethinking Oversight in PSMF Management
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
The Value of AI in Drug Safety: Empowering Global Teams and Protecting Patients
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
Maximizing Consistency: The Power of a Benefit-Risk Strategy Document in Pharmaceutical 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.
Read More »February 11, 2025
The Hidden Risks of Noncompliance: Why Insight into Pharmacovigilance Agreement Responsibilities Matters
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
The Importance of Aggregate Safety Report Process Harmonization in Pharmacovigilance Operations
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
The Future of Signal Management: How Process Automation is Shaping the Pharmacovigilance Landscape
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
Risk Minimization in the age of AI: preparing for the future of patient safety
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
Implementing PVAO recommendations: the Orbit Approach
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
Introducing Orbit Cloud: A Right-Sized Orbit Option for Small to Mid-Size Pharma & Biotech
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
Global Coordination, Local Implementation in Orbit: The Industry-Leading Solution for Managing and Tracking Risk Management Activities
Explore how Orbit merges global risk management with local implementation, ensuring safety and compliance worldwide.
Read More »November 27, 2023
Orbit Versus a Custom-Built Solution
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
Risk Minimization 360: Two Cutting-Edge Technologies That Re-Shape the Way You Manage Your Risk
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
From Reactive to Proactive: The Evolution of Aggregate Safety Reporting
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
Orbit Implementation Best Practices
Unlock the full potential of your team's implementation with Orbit.
Read More »March 10, 2023
The Revolution of Technology in Pharma
Post-Conference takeaways from DIA Pharmacovigilance and Risk Management Strategies Conference 2023, Bethesda, MD.
Read More »February 21, 2023
Orbit 2023 - Kicking Off the New Year
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
Reaching Consensus on Core and Local Implementation
Orbit streamlines risk management by harmonizing core strategies with localized needs, ensuring effective and consistent implementation across all levels.
Read More »December 1, 2022
The Process and Tracking "It" in Orbit
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
PVA Checklist - Five Phases
Unlocking the complexity of Pharmacovigilance Agreements through five essential phases.
Read More »August 19, 2022
Recap: Modernizing your PVAs with Orbit
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
RMP and REMS: The Most Stringent Risk Minimization Measures - Restricted Distribution
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
Helping organizations move away from reactive Aggregate Safety Reporting
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
When Signal Management is the Answer to Signal Detection Challenges
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
Proactive Compliance in the Current Global Risk Management Environment
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
Orbit 6 and Beyond with Matt Rost
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
Managing Compliance in Pharmacovigilance Partnerships
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
Insights from Orbit Summit's Risk Management Panel
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
Orbit is Featured in PRA's Pharmacovigilance Newsletter
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
Task Management, the key to tracking distributed work
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
New Webinar announced: MedDRA Query Strategies
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
Global Safety in Practice: Thoughts on DIA Global 2020 Schedule
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 Proactive PVA Imperative
The successful handling of PVA obligations is a critical but often overlooked consideration.
Read More »May 25, 2020
Structured data collection: the next step in risk minimization tracking
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
Prudentia & Feith Announce MedCodr/Orbit Integration
The new integration will support Patient Safety organizations as they define their safety data evaluation strategies
Read More »April 9, 2020
New webinar announced: Globalization of Risk Management
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
Risk-based MHRA inspections and a possible end in sight for standalone signal detection in Eudravigilance...
Takeaways from the PV & Risk Management Strategies meeting
Read More »February 4, 2020
PVRMS 2020: Thoughts on the January Schedule
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
Is your Safety Team ready for the 2020's?
Risk and Safety in the new decade will be all about scaling your processes for the long-term.
Read More »January 7, 2020
The Orbit Summit 2019
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
Tracking to the Nth degree - aRMM Distribution Metrics
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
DIA Global 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
Improving Patient Safety
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
Intake, Filling Outlook's Very Big Shoes
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
Build-vs-Buy: How implementing a pre-configured PV Tracking solution will get you there faster
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
RMPs: Plan locally, track globally
Pharmaceutical companies encounter challenges with tracking and sharing CORE, EU, and Local implementation of their Risk Management Plans (RMPs).
Read More »February 15, 2019
Lots of learning @ DIA
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
A New Years Resolution we can achieve in 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
Why is everyone so worried about their Additional RMMs?
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
Q&A: Introducing Orbit Compliance Center
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 from Orbit
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
Patient Support Programs: Eating the Elephant
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
Risk Minimization in Modules V & XVI - Show, Don't Tell
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
Tracking your Signals in EVDAS
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
Automation in Safety Data Exchange and PV Agreements
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.
Read More »
Webinar: Aggregate Reporting with Orbit
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
Read More »
Webinar: MedDRA Query Strategies
WEBINAR MedDRA Query Strategies Safety Evaluations are central to Pharmacovigilance Sciences. Demonstrating consistency in retrieving data for analysis can pose
Read More »
