Most Tier I and Tier II sponsors maintain their submission documents in an electronic document management system (EDMS). It’s obvious that software that creates electronic (or paper) submissions must work with the documents managed in the EDMS. But what is not so obvious is the optimal integration between an EDMS and a publishing tool.
In a testament to operational efficiency, numerous pharmaceutical companies are borrowing a page from a practice made famous by the manufacturing industry — namely shift work. While the advantage to the manufacturing industry is essentially using facilities and equipment round the clock to produce more goods, the pharmaceutical industry seeks to synchronize regulatory affairs and operation departments around the world. The added twist to this “new” shift work is maximizing the efficiency of highly educated employees with specialized skills located around the world.
People seeking advice on eCTD publishing best practices usually fall into one of two groups: (1) Sponsors who are new to eCTD, for example, medical writers or project managers (2) eCTD publishers. The first group is usually interested in specific actions they can take to make their specific submission a success, while the latter group is more interested in strategic ideas on how to make their processes work better for all submissions.