eCTD / RPS Discussion Forum

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admin — Thu, 10 Jun 2010 13:26:00 -0400

BLOGS

eCTD / RPS Discussion Forum

RPS 101 Audio Conference Presentation – 07/21/2009

Wed, 22 Jul 2009 11:45:12 -0400

Here is the presentation from Octagon’s eCTD/RPS Discussion Forum Audio Conference on Tuesday, July 21, 2009. If you have any additional questions, please post them to the Forum and a member of Octagon’s Regulatory Affairs Team will respond accordingly.

eCTD / RPS Discussion Forum

Notes from Audio Conference 07-16-2009

Mon, 20 Jul 2009 10:10:09 -0400

Here are the notes from Octagon’s eCTD/RPS Discussion Forum Audio Conference on Thursday, July 16, 2009.

eCTD / RPS Discussion Forum

FDA Website Navigation Help from Octagon Research Solutions, Inc.

Tue, 02 Jun 2009 14:22:42 -0400

The FDA has recently redesigned its website and we realize that new website navigation can create additional challenges during your busy day. In order to minimize these issues, we have complied this series of relevant links to help you search more quickly for important information. Please feel free to bookmark these links for future reference.

All CDER Guidances on Electronic Submissions:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidanc...

eCTD Specs, Guidances and Checksums:

eCTD / RPS Discussion Forum

Notes from Audio Conference 05-27-2009

Mon, 01 Jun 2009 20:27:54 -0400

Here are the notes from Octagon’s eCTD/RPS Discussion Forum Audio Conference on Wednesday, May 27, 2009.

eCTD / RPS Discussion Forum

ViewPoint FUSE ®

admin — Fri, 06 Feb 2009 11:39:47 -0500

Better Data Faster

ViewPoint^® FUSE is an integrated EDC software platform which is unique to the industry. It is comprised of a series of reusable eCRF screens that are fully validated with complete validation checks/display rules.

eCTD / RPS Discussion Forum

eAF

admin — Fri, 16 Mar 2007 14:46:58 -0400

Am I required to submit the electronic application form with eCTD?

eCTD / RPS Discussion Forum

Submission Document Authoring

admin — Wed, 07 Feb 2007 13:41:19 -0500

Do most organizations have a style guide that is being used for submission documents?