NewswireToday - /newswire/ - Wayne, PA, United States, 11/18/2009 - New functionality supports global authoring of eCTD regulatory submissions.

News Facts
• CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a pioneer and leading provider of breakthrough software and services to the life sciences industry, today announced the release of its newest version of StartingPoint® global submission document authoring template suite.
• 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, significantly improved functionality and compliance with Windows 7. New functionality includes:

• Enhanced error identification and management.
- 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
- 1.6.2 Pre-NDA Meeting Background Materials

Supporting Quotes

• “This latest version of StartingPoint is the direct result of Octagon’s extensive and practical eCTD and CTD authoring expertise,” stated John Lawrie, vice president, Process Consulting. “StartingPoint is used in hundreds of electronic submissions to multiple global agencies and is quickly becoming the industry-leading authoring solution for organizations seeking to minimize document rework.”
• “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.

Supporting Resources

• Octagon Pressroom
• Octagon’s Social Media Center
• To see a demonstration of StartingPoint 4.0 or to learn more about Octagon’s integrated product and service offerings, please contact Octagon Research Solutions, Inc. website.

About Octagon Research Solutions, Inc.
Octagon (octagonresearch.com) is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD, CDISC and EDC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Harrow, UK. Octagon’s EDC Operations are located in Mountain View, CA.

Agency / Source: Octagon Research Solutions, Inc.

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