NewswireToday - /newswire/ -
Wayne, PA, United States, 2010/01/08 - ViewPoint®, Octagon’s eCTD Viewer and Octagon’s eCTD Validator Support EU Module 1 Specification, v. 1.4.
Octagon Research Solutions, Inc., today announced support for recent European Union requirements for electronic Common Technical Document (eCTD) Submissions with the general availability of the following new versions of its eCTD product suite:
o ViewPoint® v.3.12.0
o Octagon’s eCTD Viewer, v.2.6.0
o Octagon’s eCTD Validator, v.2.6.0
• A key feature of the new releases includes support across all three products for eCTD EU Module 1 Specification, version 1.4.
• The new product releases include support for updated attributes, naming conventions and checksum information as detailed in the 1.4 specification. The European Union applies the eCTD Specification in the European region as defined by the ICH M2 Working Group and completes it with the EU Module 1 specification.
• “Support for the latest EU specification is critical to Octagon’s global clients who are submitting eCTD applications in the European Union,” noted Kirk Gallion, president, Octagon Research Solutions, Inc. “We are committed to supporting these updates as the industry continues to realize the global benefits of electronic submissions in general and the eCTD in particular.”
* EU Module 1 Specification, v. 1.4
About Octagon Research Solutions, Inc.
Octagon (octagonresearch.com) is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of 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 Berkhamsted, UK. Octagon’s EDC Operations are located in Mountain View, CA.