Congratulations on your first IND! Those kinds of accomplishments are what make this profession fun.
You describe a common experience in small companies, particularly if you don't have professional writers controlling the documents. Regardless of company size, however, I have not had good experiences when multiple authors are going into the same document and editing because invariably the formatting gets corrupted. We use BOX, which is more simple to use than Sharepoint, and the intention is that content experts be able to edit a document in BOX but most authoring occurs by email. I will "allow" edits in BOX or by email but at some point as the document "matures" a document owner is identified and only that owner can make further edits to prevent corruption of the file.
The second biggest challenge - and what having a document owner solves under this "system" - is version control. If I own a document, and regardless of what anyone else writes, if only I am incorporating those edits into the official document, version control is under my control and no longer a problem. It just has to be clear to the team who the owner is and what the timelines are for contributions. That is actually one of the big advantages of the small company environment - a few experts all aligned in getting a singular job done.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 23-Sep-2019 22:31
From: Anonymous Member
Subject: Process for IND filing organization
This message was posted by a user wishing to remain anonymous
Hello RAPs Community Friends,
I am an industry veteran but relatively new to Reg Affairs at a small US biotech. I've just completed my first IND in this new role and found it both satisfying and a bit like herding cats to control and collect the key documents and get colleagues to adhere to timelines. We do not have a formal document management system and though we have Sharepoint, our company culture is to review documents via email (i know, not the best system..). It has been challenging to get people to use Sharepoint.
I'd like to hear from anyone with any insight, especially if you are working without the resources and infrastructure of a larger company:
- How do you manage document sharing and review for filings?
- What tools (trackers, reports, etc..) do you use to keep track and help with transparency?
Many thanks in advance.