eCTD templates set the tone at the early stage of drug development for a smooth, standardized presentation of information in future regulatory submissions. Templates are favorable when compared to creating documents from scratch. Authoring templates make it easier to write summary documents and easily repurpose information from multiple reports without worrying about reformatting. High-quality documents are a precursor to successful submissions. Leveraging templates is one way to help make this possible.
The value of an early stage life science company is tied to its documentation. Transitioning from an informal environment where documents exist on local desktops, email exchanges and in extreme cases of old world technology, filing cabinets, to a structured, digital document system is a key step in securing a company’s intellectual property. Risk of losing files or the most recent versions of files, due to simple human error, increases in orders of magnitude as your stack of documents and team grows over time.
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.