Boehringer Ingelheim and CDC Solutions develop pilot program for electronic submissions
According to the partnering companies, the prototype will be designed to integrate an XML-based platform for an electronic Culmative Table of Contents (CTOC) with PDF and SAS XPORT documents. Boehringer Ingelheim will assist with the development of a prototype to meet the practical needs of the pharmaceutical industry.
The solution is designed to support future specifications as the International Conference on Harmonization (ICH) completes the electronic Common Technical Document (CTD) project.
"The importance of the CTOC project is that it maps out the direction in which the regulatory bodies are moving - toward a more user-friendly electronic submission process," said Dirk Ehrhard, Global Project Leader for Document Management at Boehringer Ingelheim. "In anticipation of the FDA's addition of an XML-based navigation, pharmaceutical companies around the world will have a definite target to aim for in terms of putting a new electronic structure in place. CDC Solutions is leveraging its existing technology to take an active role in this development, which is a critically important step toward a more efficient submissions process."
"On average, IND submissions may comprise anywhere from 10-30 volumes, each consisting of several hundred pages," said Don Palmer, Regulatory Specialist at CDC Solutions. "On the high end, however, we have seen submissions in the 50-70 volume range. Add to that as many as 500 amendments associated with a particular IND, and it is easy to understand the need for submission-level organization. The dynamic nature of an XML-based CTOC makes sense logically, and is a technology that CDC already uses in its publishing software products. The CTOC concept greatly improves the navigation and searching capabilities for the FDA reviewers, as well as the sponsor pharmaceutical company."