PRZOOM - /newswire/ -
Wayne, PA, United States, 2007/02/26 - Chairman and CEO, Jim Walker of Octagon Research Solutions, Inc., announced today that Biogen Idec, (NASDAQ: BIIB), will begin using StartingPoint® and eCTD JumpStart™ as the foundation of their electronic submission strategy.
Company chooses StartingPoint® and eCTD JumpStart™ to implement global authoring standards.
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, announced today that Biogen Idec, (NASDAQ: BIIB), a premier biotechnology organization that has pioneered important medical advances worldwide, will begin using StartingPoint® and eCTD JumpStart™ as the foundation of their electronic submission strategy.
“We are very excited that Biogen Idec has chosen both of these solutions which will provide the company with a strong electronic submission foundation and further develop their eCTD processes” stated John Lawrie, vice president, Process Solutions at Octagon. “Our StartingPoint and eCTD JumpStart solutions encapsulate deep domain knowledge and the practical experience of some of the industry’s leading experts in electronic submissions and in combination with our training and consulting services, provide a basis for efficient implementation of eCTD standards and processes.
Octagon’s Chairman and CEO Jim Walker added, “The market validation we receive when a global biotechnology company such as Biogen Idec chooses the unique combination of technology and expertise inherent in our StartingPoint and eCTD JumpStart solutions, confirms that our targeted eCTD solutions are resonating throughout industry.”
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. StartingPoint® 2.2 Global eCTD Template Suite, originally launched in 2003, includes a master template, which defines formatting, and automation functionality, over 175 authoring templates across all five CTD modules, validation test scripts and a comprehensive user guide, EU Content templates for Module 1 and a PLR (Physician’s Labeling Rule) button, which enables users to easily generate the compliant two-column format required by the FDA. StartingPoint’s automated toolbar provides functionality for custom styles, pre-formatted tables, page orientation, frequently used symbol characters, and instructional text regarding content and format.
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.
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 electronic submission expertise, a holistic process approach, deep domain knowledge, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Amersham, UK.