How long does it take to write an IND submission?
Answer: It depends on several factors.
Your team can write an IND within 4 months provided that all supporting data are available before the writing starts*. While solid data is at the heart of an IND, a timely submission requires advance planning, preparation, and effective project management.
When Acumen manages an IND, the submission manager partners with the sponsor team to implement a robust structure before the writing even begins. These are the essentials we can provide:
Timelines. Your team will need a roadmap in the form of well-informed, integrated timelines for all submission documents. The timelines need to reflect dependencies within and across modules, highlight bottlenecks, and be adaptable to manage emerging issues. Tip: this is precisely what we have built using Smartsheet. Learn more here.
eCTD templates and authoring tools. These are indispensable to create submission-ready files from the very start. Make sure your eCTD templates are up to date and easily accessible to the authors, and that they know how to use them. Tip: Acumen has 400 eCTD compliant templates supported by time-saving writing tools. View templates here.
Document development system. Your IND will require a document review platform and a clear process that covers end-to-end document development. Authors, reviewers, and approvers need to know what to do, where and when. Our submission managers work with your team to organize and manage all the logistics around document development.
Let Acumen help you shorten the road to your IND submission. Contact us today!
Fernando Venegas, Head of Operations and Quality
*There are a few exceptions, such as late-arriving GLP tox reports, CMC stability and release specs. These merit a separate discussion.