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Wayne, PA, United States, 2007/02/20 - Chairman and CEO Jim Walker of Octagon Research Solutions, Inc., INO Therapeutics has selected Octagon’s StartingPoint®, eCTD JumpStart™ and ViewPoint® eCTD Complete solutions to launch their eCTD submission capabilities.
Company Chooses Three of Octagon’s Integrated, Cross-functional 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 that INO Therapeutics has selected Octagon’s StartingPoint®, eCTD JumpStart™ and ViewPoint®) eCTD Complete solutions to launch their eCTD submission capabilities.
StartingPoint is a global eCTD template suite that supports eCTD document authoring. eCTD JumpStart is a collection of standards and best practices supported by expert services that provide a foundation for eCTD submission processes. Finally, ViewPoint eCTD Complete is a technology solution that pairs Octagon’s innovative technologies with expert support services to provide core submission capabilities including compilation, issue management, viewing and validation.
Richard Bourne, vice president of Regulatory Affairs at INO Therapeutics, LLC., noted, “We are developing a strong foundation for becoming eCTD-ready. The solutions we chose complement our current capabilities and provide practical guidance on eCTD throughout the submission process.”
In recent months, the U.S. Food and Drug Administration has announced a change to a proposed rule and conducted a Part 15 Public Meeting on the topic of electronic submissions, eCTD and electronic data.
“We understand the shifts in the regulatory landscape and we are proactively preparing our organization to transition to eCTD. This is a strategic priority for our company, “added Bourne. “We chose Octagon’s solutions because they understand the business requirements surrounding submission development and their solutions clearly demonstrate that practical knowledge.”
Jim Walker, chairman and CEO added, “As we follow the recent agency activities around electronic submissions and electronic data, we see that implementing eCTD is becoming a priority for many competitive organizations in our industry. We look forward to providing progressive companies like INO Therapeutics with a full suite of integrated solutions that support efficient eCTD processes and reach across their organization to provide recurring value to their R&D professionals.”
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.
About INO Therapeutics, Inc.
INO Therapeutics is a multi-national specialty pharmaceutical company, with core competencies in development of late stage drugs and marketing of pharmaceuticals and delivery devices. We are committed to research and development focused on meeting unmet medical needs in critical care medicine.