NewswireToday - /newswire/ -
Wayne, PA, United States, 2007/03/21 - CEO & Chairman 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 the release of Octagon’s Global eCTD Guidance Interpretation.
New Offering to Provide Expert Interpretation of Global eCTD Guidances.
The new offering was developed by Octagon’s Regulatory Affairs, Regulatory Operations and Process experts and includes detailed documentation of standards and practices that support the efficient development of compliant eCTD deliverables. Computer based training is also included in the package.
“The global eCTD Guidance Interpretation represents hundreds of hours of research and analysis of electronic submission guidances and specifications by experienced industry professionals,” noted Nancy Smerkanich, vice president, Regulatory Affairs. “We understand how important it is to have a common organizational understanding of industry guidances. The Global eCTD Guidance Interpretation will save company’s significant time and resources because they won’t have to reinvent the wheel. We have done the work for them and we present it in a clear and concise manner. We are also offering additional assistance to companies that choose to customize our interpretation to align with existing organizational standards.”
The Global eCTD Guidance Interpretation includes detailed documentation, training and optional consulting services that can support customization and deployment of the interpretation across the US, Canada and Europe. It is available on a subscription basis and scheduled updates will reflect relevant changes in the regulatory landscape.
Jim Walker added, “The Global eCTD Guidance Interpretation continues our legacy of practical domain expertise. Out of the box, this offering represents a huge resource and costs savings for companies implementing eCTD. We are continuing to provide unparalleled value to our client base with integrated solutions that address mission critical aspects of eCTD capability development. We are proud to bring this offering to the market at such a crucial time.”
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.