Signal Management
Signal management is arguably the most important activity within pharmacovigilance. After all, the whole reason to set up and operate a pharmacovigilance system with all its many processes is to identify and assess any potential safety risks and changes to the benefit-risk profile of medicines that are on the market. That’s what signal detection, signal validation, and signal analysis are meant to achieve.
With the Tepsivo pharmacovigilance system, you will rest assured that all safety relevant data is diligently assessed following our signal management processes.
How do we do it?
As with every other part of our pharmacovigilance system and processes, we perform signal management activities through our unique Tepsivo Platform. By its nature of centralizing all ongoing activities and collected data in one place, it allows us direct access to the dataset we need to look at in analyzing any information potentially relevant for the safety profile of your medicinal products.
Thanks to our tools and processes, we’ve removed tens of hours that are typically needed for overhead admin work around signal management. This makes our data analysis much easier and focused on what matters, allowing us to perform critical assessment of the data at hand. Furthermore, we’re able to link any validated signals with PSUR/PADER development.
Why is our signal management process better than elsewhere?
The primary goal is the same: identify any safety risks, analyze them, and if needed, escalate to authorities and the public. But what’s just as important is the ability to achieve this at the highest efficiency possible, meaning lowest time and cost spent. This means taking a pragmatic approach and avoid any nonsense, duplicated work to justify longer hours of work, as is practice with most of our competitors.
While signal management is crucial, the reality is that in most cases it is largely just a safeguard and little data is in fact analyzed. There are in general very few valid signals, which begs the question whether it’s justified to impose signal management requirements on MA Holders. It does, because it is a safeguard, and we never know…
…BUT, and this is vital, we need to remain practical and take a sensible approach in analyzing the data, choosing a logical frequency and right sources. This is contrary to industry practice where signaling may sometimes take weeks of work with different trackers, logs, meetings, and reports each quarter that all in the end show no valid signals. Often, all of it in attempt to justify higher workload…
None of these old-fashioned methods fly with us. In the Tepsivo pharmacovigilance system, we perform signal management with the closest attention to detail, wherever it is relevant. And, just as valuable, we cut through the noise of irrelevant data.
More about our approach
to signal management
Provoking PV system changes
We are a stakeholder in the PV industry as a pharmacovigilance provider, and we are also known for our honest criticism of the current pharmacovigilance landscape, especially in Europe. We’re convinced that the existing standard processes are highly inefficient and European legislators and EMA have failed to implement any metrics of process effectiveness.
But to its credit, in Europe, EMA has centralized a large part of overall signal management requirements with its pilot program where most MAHs are no longer required to continuously monitor EudraVigilance data, relieving them of a significant workload. Unless your medicine is on the EMA pilot list, your actual signal management activities can be in fact fairly limited.
Maximizing eficacy, not billable hours
It is then important that you select the right pharmacovigilance provider who can guide you through the signal management process with your interests at heart, in the most efficient way possible, and without any duplications.
Reality is that many vendors out there still perform regular weekly downloads from EV, even as you as MAH (likely) don’t have that obligation, and you can guess why… (€)
Of course, that does not happen at Tepsivo. All of our pharmacovigilance processes and tools, including signal management, analysis, and validation modules of our Tepsivo Platform, deliver the most efficient and highest quality service.
Related reading on signal management and data analysis written by our COO Martti Ahtola:
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