Pharmacovigilance Literature Screening
– recognized also as medical literature monitoring (mlm), surveillance or search –
Service summary
– Scientific journals can be sources of Adverse Drug Reaction reports and other safety relevant information
– It is mandated that Marketing Authorization Holders ensure thorough and regular screening of the relevant literature
– Depending on your market coverage, you will need to perform monitoring in global databases such as PubMed or Embase, but also may need to take a closer look at non-indexed local language journals in your respective markets
Why tepsivo?
Tepsivo Platform with its literature monitoring software module manages global and local literature review around all world the world from one place. Major benefit is in removing all unnecessary admin overhead heavily pushing down total costs, all in line with our value-based philosophy.
✓ Automated reporting
✓ Full audit trail of actions
✓ No admin overhead
✓ Lowest cost possible
✓ 100% legally compliant
For simplicity, we follow the usual split between global and literature screening. Global literature monitoring meaning the weekly search in databases such as PubMed or Embase and Local literature screening to mean the searches in non-indexed journals published locally around the world.
Both global and local PV expertise is required, and that’s where we can help.
Global Literature Screening
Global literature screening is one of the key pharmacovigilance obligations you have. Depending on what your portfolio is, it can either be one of the easiest tasks or one of the most time-consuming ones. Either way, Tepsivo literature monitoring service can fully cover your regulatory duties.
Do you have one or a handful of products on the market?
First things first. Let us check if your substance isn’t already monitored by EMA’s Medical Literature Monitoring service. If yes, then there is no reason to duplicate the effort. To its credit, EMA has gone in the right direction by centralizing the screening in one place for many substances.
If your substance isn’t monitored centrally by EMA, you will need someone to screen the databases weekly and track any relevant results. That’s what we can easily do. Thanks to our automated Tepsivo Platform, it’s very easy for us to track and report any outputs of the screening, further dropping down the total price.
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Do you have a large portfolio of products?
If you represent a generic company with a large portfolio, the global literature screening may in fact become a colossal cost for you. Here is where you need to automate.
We’ve spent a lot of time going through the best possible options how to optimize literature monitoring and decrease the associated time effort and cost. Reach out to us to discuss your situation and we’ll prepare the most fitting solution for you. Most likely a combination of an AI-powered search tool and our inhouse Tepsivo Platform, automating both the screening time as well as the reporting side of the process.
Local Literature Screening
Are you all caught up with your reading all over the world?
With Tepsivo global PV network covering over 150 countries, you can be assured to comply with the literature monitoring requirements from EMA and regulatory authorities around the world. Based on your drug and commercial status in your respective markets, we will prepare your literature screening strategy for each country individually.
Our literature screeners will use their PV and relevant language knowledge to define the right keywords and, especially, to select the most relevant journals. To ensure you don’t miss any potentially relevant information, the journal selection is crucial for a good literature monitoring strategy, and it’s best done by specialists with thorough knowledge of the medical environment in their relevant countries.
What makes us special?
Our pragmatism and belief in efficiency in contrast to greed.
It is our view that local literature screening in non-indexed journals is an outdated requirement, and it shouldn’t really exist in today’s world, at least not in the form it is required now. That is, if we believe that pharmacovigilance process effectiveness should be a measurement of quality.
If you’re present globally, local literature screening will constitute a large part of your PV budget. We’ve been making arguments to the EMA to remove this requirement but to no avail. It’s here to stay and local literature screening will remain expensive for pharmaceutical companies.
So if EMA and legislators are not taking action, what can we do?
We can automate the process and heavily bring down your total costs.
Our unique Tepsivo Literature searches through thousands of sources based on keywords and sends auto-translated abstracts to one central place that is Tepsivo Platform. All with 0 people trapped doing mundane activities.
Plus, thanks to Tepsivo Platform, we removed the traditionally heavy work in reporting/tracking/reconciling that usually adds so much extra time effort to an already time intense activity. Especially in global operations.
For traditional pharmacovigilance providers and CROs, local literature monitoring is a financially lucrative activity. But we’re not greedy, we don’t believe that it belongs, in its current form, to the field and it certainly doesn’t meet the criteria of what we see as value-based healthcare. That is what we developed Tepsivo Literature, saving time and money on meaningless tasks
Want to learn more?
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Let’s have a chat
Whatever you needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.
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