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Is it time to turn your reporting structure ‘upside down’?

How familiar are you with the current issues around eCTD, that is Electronic Common Technical Document?  (If your primary interest is Europe, see here for more information:  and if your interest is in the US, see here)

If you are unsure about the term, which I admit isn’t that user-friendly perhaps, then the good news is it’s not that hard to unpack. All eCTD really means is a standards-based way the industry is going in to move from delivering drug marketing applications to regulatory authorities not in paper, but in an electronic format. The main drivers include a push by the ICH (International Conference on Harmonisation) process – which is to say US, Japan and Europe – which wants to use one common format: hence eCTD. (Please note this is for information on human drugs alone, although there is work going ahead in the veterinary field as well as in cosmetics.)

There’s no excuse, of course, for not being up to speed with all things eCTD if you work in your company’s Regulatory Affairs Department! Anyone, in fact, charged with the submission of important product information to an authority needs to be on top of the standards and its issues.

Today, though, I don’t want to talk to you about eCTD, but to discuss some issues that might put it in a slightly wider context. In fact, I want to go really ‘big picture’ and talk about something that I think is going to have a big impact on all of us in the industry: Big Data.

Many commentators on the impact of Big Data – commentators across the board, so not just in our sector- say that this year looks set to be the year of integration. That’s to say, the integration of Big Data with other core management information systems. And what I want to look at is how eCTD and Big Data are going to start coming together in what we might call Regulatory Information Management, or in its abbreviated form RIM.

Why so many systems?

To get there, think about how a drug is developed. A long time before you can market a drug which works in the human body, you have to do years and years of basic lab work then, although not in all cases, clinical trials; ideally then you have trials on humans and so forth. And then it comes to first contact with the agencies, who  have to give their approval: and if all that goes well, then we come to the electronic submission stage and finally to eCTD to get the final, final approval and launch your great new drug on the market. You only have a number of years in terms of your patent protection for this particular drug, as we will all know, and so you need to maximise that.

All well and good so far, I hope. But where does Big Data come in? In the compliance and legislative aspect, I am going to submit – which may surprise you if you only see Big Data as about being a research tool, a way to find patterns and so forth that you might not be aware were there.

Let me explain what I mean.  Think of a pharma company’s clinical trials system, perhaps some Oracle-based system. It might also have a submission management system which might use SQL Server, say – and a pharmacovigilance system which might be on a mound in the Cloud, perhaps.

But when you think about it, the same active component (the thing that will power the drug) is in use in the clinical trial, the submission process and it is used in the pharmacovigilance side, too. And you have to track it. That is exactly the same information you are using – only spread over three, four, five or maybe six different systems.

I am not sure that makes such great sense. And so I think what we have to do is turn it upside down.

What do I mean by that? Well, why don’t you keep everything in one place, not in multiple systems? We call that a ‘single place of truth’. So with the Samarind system, you can use the same database to actually do your clinical trial because you have the same data as from your earliest work; and you use the same system to create your eCTD, because there is still the same active elements in there – and very soon you can use the Samarind system for all your pharmacovigilance requirements, too, to help you track the same drug’s progress across a huge sweep of time.

The consultancies say they will help you do this – but by integrating those five or six systems that I talked about. Well, we’re saying the opposite: put the information in the correct place in the first place!

Next time I will dive a bit deeper into why I think that integration idea may not be that helpful to you, as a way to making this logic a bit more transparent.

For more information about regulatory issues, please visit:


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