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Wayne, PA, United States, 2006/12/04 - Octagon Research Solutions, Inc., today announced the release of StartingPoint® 2.2, the most recent version of its Global template suite, which Octagon’s continued innovative approach to improving submission authoring processes..
StartingPoint®2.2 Global template suite includes new features and functionality that support global submission standards and incorporates region-specific solutions
Chairman and CEO, Jim Walker of Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, today announced the release of StartingPoint® 2.2, the most recent version of its Global template suite, which represents Octagon’s continued innovative approach to improving submission authoring processes. Octagon’s StartingPoint 2.2 template suite enables rapid deployment of authoring standards across functional areas to facilitate efficient authoring of all components of the eCTD (electronic Common Technical Document) and includes instructional text from the International Conference on Harmonization (ICH) guidance documents as well as automation of frequently used authoring functions.
StartingPoint 2.2 has been developed by Octagon’s industry experts and is based on their insights, best practices and practical experience spanning the entire document and submission lifecycle. The new StartingPoint 2.2 features include:
· Addition of EU Content templates for Module 1
· A new one-button feature enabling users to toggle between US Letter and A4 page sizes without affecting pagination, thus, facilitating submission document creation processes for global companies planning to submit in EU and US regions
· A PLR (Physician’s Labeling Rule) button, which enables users to easily generate the compliant two-column format required by the FDA
John Lawrie, vice president of process solutions at Octagon, noted, “With the recent FDA CDER announcement regarding the withdrawal of three electronic submission guidances, eCTD submission document authoring, review and approval processes and standards have become even more critical.
StartingPoint 2.2 continues to evolve to support this changing environment and to allow document authors to focus on content. The new release combines user-requested features with other innovative enhancements that will simplify the tedious formatting tasks associated with traditional authoring methods.”
Octagon understands the challenges of implementing global authoring standards across an organization and how the implementation of these standards can become a catalyst for change. Octagon’s suite of eCTD solutions includes eCTD JumpStart™. eCTD JumpStart offers documentation and consulting services designed to facilitate the efficient creation, management, and retrieval of eCTD compliant submission-ready documents. These components have been honed through Octagon’s collective breadth of knowledge and experience in the preparation of hundreds of electronic submissions and when used with StartingPoint 2.2 create a solid foundation for the submission of an eCTD.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through 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 Amersham, UK.