By Dr Olaf Schoepke, Director of Strategic Development, Samarind RMS
Last time I blogged here, we spoke about how important drug information can get spread around multiple systems. We believe that clients are finding this more and more an inefficient way to work, which is why we are starting to recommend that instead they move to ‘flip’ data – keeping it on one system that can then be the source for when it needs to be driven to where it needs to be at the right time in the whole massive research-trials-approval-pharmacovigilance-reporting process.
If you want to know why, think about those big systems, the five or six trails or submissions structures which you are probably currently working with. So, when you think about these silos, for example, if you have to use four or five silos for four or five systems, how do you combine these? At the moment, you take one system and you integrate it with the others. Say you currently have a kind of base, a foundation, which is fine: now you can link system 1 to system 2 and then system 2 to system 3 and back to system 1 and so on.
Yes, you’ve linked the silos well enough (arguably). But to continue with my ‘flipping’ scenario, if you turn these silos upside down, then you have the database on top and you can see that you are just plugging in all these applications, these silos, ‘underneath.’ So if you want to have clinical trials functionality above this database – you plug the silo in. If you want to have eCTD submissions out of the same database – you plug this one in, too. And if you want pharmacovigilance to use the same data, then you plug that one in, too.
That has to be a much better architecture than trying to go ‘horizontally,’ from our system 1 to our system n. Hence the power of turning it upside down: you make the database the single place of truth, your common denominator for all the silos.
Same information – different departments
Here’s the problem: not enough people are doing this as yet, which means they are not reaping the benefits of the approach.
But, you may well ask, how would I even get there? The first thing is to understand where you keep all the information within your company. Like most big organisations, you have different departments working with the same information, so you might have spreadsheets in one department, you might have an Access database in another department and you might use Oracle in the next. But you can see that in reality, they all have the same information. The biggest problem you’re going to get to unify all this data is really to understand firstly where the data is – and secondly which data is actually correct.
On that last point, think about all the issues that came up with EVMPD data on the pharmacovigilance side.
What the EMA found after it looked at the data submitted by the industry was that it was full of mistakes. Indeed, we shouldn’t be surprised: for this is exactly what happens if the data is in too many places – you don’t know which one is the last edit and you don’t know who changed it. The idea of a ‘single place of truth’ would really help there, as it’s the best way to deal with single instantiations of data that can be much more easily checked than multiple ones.
And there’s a pressing market reason to get this right. The authorities are inspecting a lot more; they want to know where the data is coming from, they want to investigate the quality of the data. And they want to look at the systems themselves. So if you are a manufacturer of a specific drug, you might have to come up with a certificate of your actual manufacture. You might sell it in the UK but you imported from, say India, so you need a certificate to say it was made according to certain international standards. Again, if you keep the data in different places, with one ‘manufacturing’ point of view or one ‘pharmaceutical’ point of view, you always have to think about: how do you make it consistent? How do you keep it in sync?
Next time, I will talk in more detail about how Samarind can help you get to just this very place – the place of the ‘single’ place of truth.