Tackling the discovery dilemma of eCTD – Pt. 2

HAYSTACKID Vice President of eDiscovery & Digital Forensics Discusses FDA Legislation’s Impact On Forensics, and New Tool to Quell Relevant Challenges

In the first segment of this two-part series, HAYSTACKID Vice President of eDiscovery & Digital Forensics Michael D. Sarlo explained some of the fundamentals of the FDA’s latest regulatory overhauls regarding eCTD. In this second part, he takes us deeper into eCTD and explains the new module HAYSTACKID created to help relevant clients overcome the various discovery challenges involved.

Okay, so basically you are saying that eCTD has a lot more weight, information, and moving parts than typical load files seen in eDiscovery?

Yes, absolutely. Then you tack on the sheer ferocity of the FDA’s regulations, standards, and enforcement, and you can probably understand just how unprepared most relevant organizations and litigators truly were.

Can you take me through the eDiscovery process for eCTD reviews and search without the new module that HAYSTACKID created?

I mean, no?

I’m sorry, was there an issue with the question?

No, it’s just you’re asking something that would be, very simply, impossible. Absolutely impossible and not even worth trying, really. You’d be looking at files that appeared named, there would be feeds, and potentially some type of structure, but nothing that actually correlates to what eCTD is.

Generally, what you have is a data package, and to fully understand the information about that data in its data package, the eCTD filing, you need to be able to parse the eCTD file.

Now you can open it up, the eCTD file, and start to try to link this to the files, but it would be very difficult if you didn’t develop a way to handle it. What you wouldn’t get is a way to visualize it easily. For certain types of litigation, it’s important to understand the process around eCTDs, and to realize that there’s a lot of communication happening. And being able to see where documents were added, tracked or removed, is very specific, and that’s a feature we built into our application that you wouldn’t be able to use unless you use our eCTD module.

There’s also a lot of folder structure that correlates to the way you would use folders in a paper-based scenario. If you were submitting a ton of paper, you would have to track certain things contained within that eCTD. And, a very unique element of an eCTD filing as far as metadata properties are concerned, is that they have folder-like metadata. So, for computer files, typically we’re not interested very often in the metadata of a folder, but more so the files that get produced for opposing counsel in a typical production.

On the other hand, eCTD is very rooted in the metadata about folders. You would not have any of that unless you parsed the whole thing, loaded into Relativity, re-created the folder structures, the documents therein, and also at the same time that would not give you the history of the documentation – you’d need to have the history of the application and all communications with regulatory entities throughout the lifecycle of the eCTD load file based on the documents that were associated with the eCTD.

That is to say, you have to have the metadata – to look at the communication profile and the structure of the eCTD, to see how this application was being constructed – Did the process ever break down? – and here’s the email so you can see where the file was at.

Alright, that makes sense. So basically, it would’ve been impossible and even at best, would take far too much time and demand insane amounts of money to complete?

Honestly, to make sure that we are crystal clear on this, I would really say it would be impossible, simple as that.

Okay. Now, take me through what this eCTD module that HAYSTACKID developed actually does.

First off, from the eDiscovery in the trenches aspect of this, doing anything manually is very difficult. There’s a lot of process involved in trying to parse the eCTD, there’s many different versions of the eCTD on a regional basis, country-to-country, and the format is constantly updating. To stay aware of this, and constantly re-learn a process to break each down, is difficult in its own sense, unless you have an understanding of it.

From that perspective, our tool allows our team to view the eCTD load file and the associated folder structures and supporting files, to point right at it, and upload it directly into Relativity where all of the metadata fields are automatically filled. Wherever there are attachments, we break those down, metadata is populated from folders to documents which is the way you’d expect to produce that metadata in any type of legal discovery context. Subsequent extended fields, the folder structure which you’d have to parse manually, is also created, and there’s one final attribute.

There are the extended XML files that support the eCTD. Our application will parse the many, hundreds or sometimes thousands, of sub-load files that are associated with the main eCTD.

So from an eDiscovery perspective, imagine having to load hundreds of load files related to a single load file, and now having all that automatically traverse and parse everything for you.

Now from the eyes of the reviewer, we want to make this as simple as possible. The goal for a reviewer, or attorney, is to turn this into a format and structure that they’re used to seeing. An attorney is used to being in a review platform, they’re used to having the functionality of a review platform which includes the seamless visibility necessary to take a look at documents, to understand them, and to take notes about those documents in a collaborative fashion.

And we’re leveraging the normal review workflow, but also exposing the contents of the eCTD submission at the same time. So, when our clients interact with the file, they’re presented with an experience they’re familiar with.

At the same time, they’re able to fully understand the application. They get to see it, like they used to back when it was all paper, and it really has the structure and format that was lost during the digital transition. And certainly there’s proprietary platforms that are able to assemble eCTD load files, but they’re so specific, they don’t provide any of the features that a litigation/investigation review platform would, and they’re really just made to create these files.

So, we have a whole new marketplace that’s completely driven by user experience. It’s not necessarily having the flashiest or greatest – brightest lights – it’s about making something that is incredibly complex very easy and repeatable. I think that’s where we’ve had success with the application, and that’s where it’s made a lot of sense with certain buyers, such as in compliance, in legal, really those who are assembling eCTD and those who are dealing with extracting eCTDs.

These are all major pieces of intellectual property for our clients because they contain the entire lifecycle of a drug, and we’re exposing it all in a format that they already have experience with.

Anyone who uses Relativity will be able to do it all in there, they’ll be able to review it right away and have a great understanding of the application, which is why our tool makes it so much easier.

When it comes to a production, from an eDiscovery standpoint, trying to produce these files and their metadata is just as hard as parsing it. We’re able to produce, to an opposing party or attorney agency, all of the metadata in a format that they’re used to seeing, in a way that makes it easy to redact information, to put specific documents in front, and allows the most relevant pieces of an investigation to be exchanged to the other side, or just to be reviewed.

I really think this is an experience-level piece of technology, and I think that we very much streamlined and connected the dots between what is a very complicated process.

To go back to something you mentioned – if the module is that good at let’s say keeping all of this information organized and visible, would it be useful for pharmaceutical companies and others that are producing the actual applications?

Absolutely, the module lives on what is the most-well-known review platform in the world. We strategically chose to connect with Relativity, though we connect with other platforms as well.

What it allows you to do is leverage the collaborative aspect platforms that do eCTDs – that create eCTDs – really are not great at supporting. They’re really not that well-suited to reviewing what you’ve created. Oftentimes you can have different kinds of actors who need to provide their input into these files. You can have a consultant who is coming in to walk you through the submission process.

Maybe your security makes it difficult to provide third-party access to this highly critical intellectual property. Existing platforms make it very difficult to get these things done and track them properly.

With our solution, they can put the eCTD module right into Relativity to track individual users who you need to review it, record those, and communicate back through the platform, which is certainly a wide-reaching demand in today’s world.

Are you planning to make more changes to the eCTD module?

Of course. As new eCTD standards come out, as the format changes – eCTD is a format of a load file, but the specifications around that format will be updated as the regulatory agencies update their process – our module will change. So we track that and we’re continuously supporting different types of eCTD. We’re definitely still building new features into the platform.

Really, we’re connecting all of the dots, and eCTD is just another matter of many that our clients are dealing with. We’re trying to connect tools to other tools ad infinitum, we’re working on some connectors directly into certain eCTD creation platforms that dynamically link Relativity, eCTD review module to those repositories, and we’re working on integrating them all with other enterprise systems.

Well, keep at it, and we’re all excited to see the next major innovation. Thank you for your time, Mike.

My pleasure.



The HAYSTACKID team remains vigilant and driven toward being the best possible partner for organizations in every industry through creative and valuable innovations such as this eCTD module.

We thank Mr. Sarlo for his time. Check back soon for more insights from our knowledgeable team!”