Tackling the discovery dilemma of eCTD – Pt. 1

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

Virtually any industry even remotely related to the medical and health care fields have been under the constant and ever-changing pressures of regulatory compliance.

When looking at these transformations through the lens of forensics and electronic discovery, it is not all that difficult to identify immense risks and challenges shared by organizations that interact with medical data.

One of the latest legislative overhauls did not come from the White House or the U.S. Department of Health and Human Services, though. Rather, the Food and Drug Administration released its Electronic Common Technical Document regulatory statute for a range of submission types.

Though it might be hard to believe, the FDA’s eCTD submission demands are arguably even more complex than other strenuous medical regulations like those that cover electronic health record systems, especially when diving into a forensics or eDiscovery project.

HAYSTACKID was quick to identify the hurdles involved, and developed a tool to help relevant clientele completely streamline and optimize their management of eCTD.

We recently sat down with our Vice President of eDiscovery & Digital Forensics, Michael D. Sarlo, to investigate this matter a bit deeper.

AYSTACKID: Good morning, Mr. Sarlo, thank you for taking the time to talk.

Mr. Sarlo: My pleasure.

So, let’s get right into it. Why did HAYSTACKID decide to create this eCTD module in 2016?

Well, we have to go back in time a bit to properly explain where we stand today and why we developed our eCTD module. First and foremost, HAYSTACKID has a long-standing history of working with clients in the pharmaceutical sector and various medical-related fields.

Not so long ago – really about a decade or so ago – those industries as well as virtually all other ones were heavily reliant upon paper-based processes. Paper records were certainly not ideal, but they represented the norm for decades prior. Suffice it to say that firms and professionals were comfortable enough with these systems, but nothing could stop the momentum of digital technology.

There was a little while when we were working with paper records in addition to electronic discovery, which was arguably the hardest time of all. As a general trend, technology giants, medical companies, and plenty others became more heavily regulated with the passing of each year. There was a quick and definitive push in eDiscovery toward wholly digital processes, and we discovered that clients had been submitting different types of applications to the U.S. Food and Drug Administration in this eCTD format.

Very much a load file – what we consider to be a load file in eDiscovery – but with some caveats.

Then, the FDA announced that it would require the eCTD format beginning in May 2017 for certain types of applications, and 2018 for the others. We discovered that there was a need to be able to review and produce data from this highly unique format, and fast. Because transformations take place so quickly in this arena, it came as no surprise that many clients were on their heels, scrambling to find a solution.

Did you look around the industry to see how people were handling this, and if there were already solutions to be had? 

Yes, of course. And, again not that surprisingly, we found that no one in eDiscovery had really been even thinking about it. If anything, we realized that this data was really just being treated as ‘normal’ data despite being anything but.

We then quickly found out that most of our clients, on the litigation side, did not even know that this digital type of load file existed. And then, as they started to catch on, premier locker cases came up involving these files, and that’s what catalyzed our development of the tool to overcome the problems at hand.

A necessity is the mother of invention type of thing?

Exactly. Interestingly enough, though, it was almost immediately clear that no one even knew about the necessity. However, again with the FDA announcing those dates when enforcement would begin, we also knew that everyone was going to have a really harsh wake-up call before long – that they would finally discover and understand the necessity and require a solution at that same moment.

What makes these types of load files so different from what people in eDiscovery would typically come across?

When we’re processing normal eDiscovery – email and container formats are generally considered normal – we can handle them from an email database. We’re processing office documents and files. Oftentimes, they’re just a file on their own. What’s different between these normal formats and eCTD, and really the subsequent files that are associated with eCTD, is that we have a database, then files associated with the database in a complex XML format, and there are several layers of tracked changes in these eCTD load files.

Tracked changes?

Yes, remember here that the FDA’s regulations demand an incredibly extensive record of the entire application’s history, every single step that was taken, every single user, etc. Dates, sharing information, just a proverbial universe of information.

It is important to understand that when we’re talking about eCTD, we’re talking about two different things: First the eCTD load file, and then the files that fit into that eCTD, or that live alongside it, you could say.

So you have the file database, and you have a bunch of files associated with that database. And there’s a lot of information contained in that database and associated it. Let’s say, for example, there is metadata related to a certain application that you are filing with the FDA, or really any other global, bio-pharma, regulatory-type agency, that must be declared.

We found that there was a lot of metadata that was being lost, and no way to view the change history around these documents either. So one thing that was highly unique about this load file format is that it tracked the ways the documents were added to, the way they were appended, and the way they were deleted.

When we create these files for eDiscovery, we just shoot out the final work product. However, because there’s so much communication back and forth between any type of company that’s submitting applications to the FDA or another regulatory agency with these entities, things can get out of hand really quickly.

There is a lot of collaboration involved in updating applications and the submissions. A lot times you get these eCTDs that are, maybe thinking of New Drug Application or Investigational New Drug Application and several other types of relevant applications, and all of it needs to be tracked.

When I say an application, I mean you’re submitting a regulatory type of application, a filing to an agency, in order to get something out of them.

You also have biological licensing agreements – these are all different things that have varying processes, and this load file format tracks the way in which the application itself is built and edited regardless of the variance in those processes. They used to do this with paper – thousands and thousands of pages – you’d have study notes, you’d have all sorts of documentation and it was very difficult to track a final piece of work product.

Certain studies are updated or new information is being plugged in or the FDA is asking for updated information for this section or that, and there, all of a sudden, is this big need to be able to review this data in a format that litigators – law firms and counsel – are familiar with. These applications, as you could imagine, boast highly responsive data types for any case that involves the lifecycle of a drug through its development stages all the way to going on the market – sometimes even after market.

In the second part of our interview, Mr. Sarlo discusses some of the other challenges associated with eCTD, as well as the module HAYSTACKID developed. Come back soon!”