The Evolution of Publishing and Regulatory Submissions

This is an updated Blog from a previous post which can be found at http://www.opentext.com/blogs/ecm_briefs/2009/02/a_year_later_evaluating_electr.html.

As with most compliance solutions, companies will put whatever is needed in place to meet the requirements, and come back and re-evaluate their decisions later. On January 1, 2008 the FDA withdrew guidance for non-electronic common technical document (eCTD) submissions, and to prepare for that, along with various other regional requirements, pharmaceutical companies implemented multiple solutions to address their varying requirements.

In early 2008 organizations were talking to me about preparing electronic submissions, and seeking the assistance of the technology vendors to help them get organized for this upcoming event. Although some had already chosen a tool, some were still looking, and most were still trying to find out more about what was available, whether they had purchased a tool or not.

To find out more about my views of eCTD Submissions and technology tools listen to this Podcast - Electronic Submissions - Pharmaceutical and Life Sciences Industry featuring Therese Harris, Program Manager for Life Sciences at Open Text and Harv Martens from the ICH M2 Working Committee.

Fast-forward to 2009, and the mood is different. A large number of companies are now looking to standardize on an eCTD submissions tool. The problem, as explained by a number of pharmaceutical companies, is that they cannot get it all from a single tool. They know what they need to do, and now they want to do it.

But this market is maturing from a technology adoption perspective; it is no longer the early adopter market that it once was. It is mainstream -- the early majority, according to Geoffrey Moore's Crossing the Chasm. This is the time when the superior products rise to the top, and others will struggle and drop-out of the market.

Electronic submission technology is at the point when pharmaceutical companies can expect to get what they require, without have to use multiple technologies for varying requirements. And although vendors need to rapidly develop their solutions to meet new and changing requirements from the various regulatory bodies, companies should expect a stronger focus on usability over the next 12 to 24 months.