OR WAIT null SECS
Octagon Research Solutions, Inc., has released version 4.0 of its global submission document authoring template suite, StartingPoint.
StartingPoint 4.0 is designed to offer standardized templates and formatting functionality to those authoring the various components of a CTD (Common Technical Document) or eCTD (electronic Common Technical Document) regulatory submission. StartingPoint 4.0 offers new content templates, improved functionality and compliance with Windows 7.
New functionality includes:
* Enhanced error identification and management o
- Expanded list of errors highlighted by the Document Validation tool
- A new ‘Report Generation’ mode that enables the user to generate a comprehensive report of all errors found in the document.
- The addition of a ‘Replace All’ feature allowing replacement of all instances of erroneous style with one button push.
* Enhanced toolbar automation that addresses common challenges with table and footnote formatting
* Automated ‘Replace Styles’ functionality that allows the user to map each existing style in a document to a specified StartingPoint style.
* New and enhanced content templates reflecting recent changes in regulatory guidance including:
- 1.16 Proposed Risk Evaluation and Mitigation Strategies (REMS)
-1.16 Risk Evaluation and Mitigation Strategies (REMS) Supporting Document
-1.6.1 Meeting Request
-1.6.2 Pre-NDA Meeting Background Materials
“The Risk Evaluation and Mitigation Strategies (REMS) content template was added to this version of StartingPoint as a result of our agency interactions and is based on just released guidance from the FDA. We are seeing an increased emphasis on the REMS and felt it appropriate to include the content template to assist our clients in developing a framework for this critical document," stated John Lawrie, vice president, Process Consulting.