The eCTD/ Document Management Connection- What say the vendors

I asked a question on Linkedin a few weeks back, namely "What questions would you ask an eCTD publisher to determine a high level of expertise?"  I got some interesting answers.

Before I go on, it may be worthwhile to explain what an eCTD (Electronic Common Technical Document) is; it's the vehicle that Pharmaceutical,  Biotechnology, and other Life Sciences firms use to transfer regulatory information to the FDA and its international counterparts. It's made up of five modules:

1. Administrative Information and Prescribing Information
2. Common Technical Document Summaries
3. Safety
4. Nonclinical Study Reports
5. Clinical Study Reports

Each of these modules contains a host of documents and making sure that the right information is put in the right place in the right format is an ordeal. Consider that one eCTD can be made up of nearly 6000 files and that an eCTD supplement can be made up of as many as 15,000. Put the wrong stuff in the wrong place and the FDA rejects it; the approval of the new drug application is delayed, stock holders get angry, and those who might benefit from the therapy have to suffer and wait.

This is a shame because the eCTD process was supposed to expedite submissions, and given time, I'm sure it will. In the mean time, Life Sciences firms will have to wrestle with selecting and adapting to a host of eCTD related products. There are 19 to choose from (produced by 8 vendors) according to George Laszlo's Laszlo letter. Companies are, of course, welcome to write their own (although I don't know of any who are doing it.)

One of the interesting conundrums of the eCTD is that the government is the driving force behind the technology. We won't even look at your submissions unless they're in the eCTD format is the rule. And while the technical work of assembling an eCTD is one matter, the business processes behind it are another issue altogether.

As James Errico of ISI pointed out in answer to my Linkedin question:

"Many of the difficult questions that life sciences organizations are still grappling with have to do with process, especially when the ship may have already sailed when it comes to best practices used in establishing eCTD-ready documents. In some cases such as CMC, nonclinical and long-term clinical studies these documents are already years old and changing their format is difficult without a thorough understanding of the impacts."

How does a company know if they've got it right? There's a whole host of available tools. Global Submit, which wrote the software the FDA uses to review submissions has two products GlobalSubmit REVIEWT and GlobalSubmit VALIDATET, Other vendors have similar products, some of them are free.

Getting back to my original question, how do you know if an eCTD publisher is any good? I say he/she must be knowledgeable about document content, configuration, compilation, and compliance. Having good communication skills is also essential, how else can you teach a multitude of users to document there work in a whole new way?

Comments

[RamonGustav]

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