Applied Clinical Trials

New Offering Signals First Fully Comprehensive eCTD Solution

Wayne, PA - June 23, 2005 - Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, today announced the general availability of three products to address comprehensive eCTD Submission Management. Octagon now offers a comprehensive eCTD Submission Management Capability that includes Process Management (standard ViewPoint functionality), Lifecycle Management (enhanced eCTD Compilation), eCTD Validation and eCTD Viewing.

Kirk Gallion, COO of Octagon noted, "It is important to understand that a true capability is a set of business processes strategically understood. Comprehensive eCTD Submission Management Capability includes process management as well as lifecycle management. If you don't have both, you don't have full eCTD capability. Our product strategy continues to focus on critical process management functionality because we understand how important this is as the underpinning of eCTD capabilities."

Octagon has added enhancements to their existing eCTD compilation. The enhanced eCTD compilation capability reflects the integration of upstream processes with final submission deliverables.

The Octagon eCTD Validator allows users to select validation rules from a predefined list and apply the rules set to an eCTD sequence. The Octagon eCTD Validator verifies the eCTD sequence meets the validation criteria and generates a report detailing the findings.

The Octagon eCTD Viewer provides users with the ability to successfully navigate, view submission content and search for submission documents and attributes contained in all sequences of an eCTD dossier.

The new offerings will leverage and complement the inherent strengths of ViewPoint, Octagon's Process Management Solution and extends the current functionality to address critical eCTD activities, including viewing submissions over the lifecycle of dossier and validating the xml "backbone," a human and machine-readable text file that holds lifecycle metadata for each component of the regulatory submission. The additional functionality will support critical process checkpoints in the submission development cycle and will provide easier access to final submission deliverables.

Jim Walker, president and CEO of Octagon added, "ViewPoint's enhanced eCTD functionality supports our vision of reducing information barriers across the organization. The critical path for getting a product to market will be significantly improved by the implementation of industry standards such as eCTD as well as the application of innovative technologies that take advantage of those standards."

About Octagon Research Solutions, Inc.
Octagon is a 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 creative use of technology. Octagon is headquartered in Wayne, PA, with offices in Boston, MA and Costa Mesa, CA. For more information please visit www.octagonresearch.com.

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