PRZOOM - /newswire/ -
Wayne, PA, United States, 2006/06/23 - Octagon Research Solutions, Inc., today unveiled eCTD JumpStart, a new high-value service offering consisting of documentation and services designed to accelerate compliance with electronic regulatory submission regulations worldwide..
Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D to the life sciences industry, today unveiled eCTD JumpStart, a new high-value service offering consisting of documentation and services designed to accelerate compliance with electronic regulatory submission regulations worldwide. Octagon recognized that for many companies, authoring templates alone are not enough. Building on the market leading StartingPoint® eCTD template suite, eCTD JumpStart will help companies move beyond well-formatted documents to creating a solid eCTD foundation.
eCTD JumpStart includes a Style Guide, Document Naming Conventions, a Folder Structure for storing and managing Regulatory Submission Documents, and Bookmarking and Hyperlinking Standards. In addition, it includes consulting services which address how Document Processes can pull together all of these standards to facilitate the efficient creation, management, and retrieval of submission-ready documents. These components have been honed through Octagon’s collective breadth of knowledge and experience from having prepared hundreds of electronic submissions since the company’s inception.
John Lawrie, vice president of Process Solutions at Octagon, noted, “eCTD JumpStart encapsulates the deep domain knowledge and practical experience of some of the industry’s leading experts in electronic submissions. Never before has such a rich resource been made available to the marketplace in a single package. eCTD JumpStart is a stand-alone offering or can be the perfect complement for our StartingPoint template suite, and will provide a strong electronic submission foundation for any company. We believe the consulting services integrated with eCTD JumpStart will be the catalyst many companies are looking for to accelerate the electronic submission learning curve.”
StartingPoint® 2.1, the latest version of Octagon’s market-leading template tool, is being released simultaneously with eCTD JumpStart. Launched in 2003, StartingPoint includes a master template which defines formatting and automation functionality, over 170 authoring templates across all five CTD modules, validation test scripts and a comprehensive user guide. The automated toolbar provides functionality for custom styles, pre-formatted tables, page orientation, frequently used symbol characters, and instructional text regarding content and format.
New for StartingPoint® version 2.1 are a host of new content templates based on Octagon’s extensive regulatory experience. These include a template to support the authoring and submission of Physician Labeling Rule (PLR) labels, a template to support legacy non-PLR labels, as well as Integrated Summaries of Safety (ISS) and Efficacy (ISE) and M3 Quality templates which include boilerplate tables based on Octagon’s extensive submission experience and ICH guidance text.
More information on eCTD JumpStart and StartingPoint® will be on display at the 42nd Annual DIA (Drug Information Association) Meeting on June 18-22nd at the Philadelphia Convention Center booth number 1809.
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 cross-functional eSub expertise, a holistic process approach, deep domain knowledge and integrated solutions. Octagon is headquartered in Wayne, PA, with offices in Boston, MA, Costa Mesa, CA, and European headquarters in Amersham, UK.