Mission3 Clinical Trial Management Solutions Products Services Clients About Us eCTD Publishing – is it a Publishing Problem, or an Enterprise Content Management problem? - By Gabor Fari – Director of Life Science Solutions, Microsoft Corporation

eCTD Publishing – is it a Publishing Problem, or an Enterprise Content Management problem?

By Gabor Fari – Director of Life Science Solutions, Microsoft Corporation

The issue of whether submission management is more of a publishing problem or an Enterprise Content Management (ECM) problem is an issue that is near and dear to my heart. I remember about 10 years ago, when I was working for another ECM vendor, our customers started asking us about eCTD Publishing tools, and whether we would support them. I started digging some more into the eCTD problem space, and what it meant for companies. I realized that the eCTD challenge also brought a real opportunity for innovation. When looked at from an ECM perspective, eCTD is all about lifecycle management and metadata management. Therefore, I came to the conclusion that this is not really a publishing problem. A publication is merely an output from the ECM system: a collection of documents or artifacts that are arranged according to certain rules and output via a delivery mechanism. ECM systems have been used almost from the beginning for publishing compound documents, and the eCTD is merely a form of this. The XML backbone of the eCTD contains the publishing rules.

Unfortunately, two things happened in the industry: first of all most of the people in the Life Sciences industry charged with implementing eCTD Publishing systems have a long publishing background, all the way back to when paper was the preferred media, and they did not realize the potential benefits of the paradigm shift. Second, there was a flurry of activity on the part of vendors to deliver these eCTD publishing tools, while the ECM vendors were content to focus on the repository aspect of eCTD. All the eCTD tool vendors were focused on integrating with the legacy ECM tools, and on an approach that I would characterize as ‘pull’ (wherein the content to be published was pulled into the publication from the ECM repository) rather than a ‘push’ approach (wherein the publication was directly assembled within the ECM system). This approach brought several major challenges with it; the two biggest ones were link management and lifecycle management. The first is a thorny problem, which was initially addressed via very ‘kluge’ approaches, such as setting the links in the ECM system, and then exporting the whole document hierarchy to a file system, otherwise the links would break. Most of the link management problems have been resolved by today – 10 years later! But it is still largely a kluge process, and the market consolidation is a good indication that the market cannot sustain more than a few eCTD vendors, as opposed to well over a dozen when the shift to eCTD started.

For More Information please click here: Mission3 Clinical Trial Management Solutions Products Services Clients About Us eCTD Publishing – is it a Publishing Problem, or an Enterprise Content Management problem? - By Gabor Fari – Director of Life Science Solutions, Microsoft Corporation