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Written by / Agency / Source: Octagon Research Solutions, Inc.

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FDANews Audioconference to Feature Thought Leaders from Octagon Research Solutions, Inc. - An FDANews Audioconference entitled: eCTDs: 'Dos and Don'ts for CDER's Electronic Requirement' on Wednesday, Nov. 15, 2006 - 1:30 p.m. - 3:00 p.m. EST
FDANews Audioconference to Feature Thought Leaders from Octagon Research Solutions, Inc.

 

NewswireToday - /newswire/ - Wayne, PA, United States, 2006/11/13 - An FDANews Audioconference entitled: eCTDs: 'Dos and Don'ts for CDER's Electronic Requirement' on Wednesday, Nov. 15, 2006 - 1:30 p.m. - 3:00 p.m. EST.

   
 
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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, announced today that Nancy Smerkanich, vice president of regulatory affairs, John Lawrie, vice president of process solutions and Pam Pagnotta, principal consultant, process solutions at Octagon Research Solutions, Inc., will be the featured instructors during an FDANews audiconference presentation entitled: eCTDs: Dos and Don'ts for CDER's Electronic Requirement.

During this audioconference, listeners will receive a thorough explanation of the need for submission lifecycle management, which requires both technology and process understanding of the challenges of tracking and managing submissions over the lifetime of the application. Additionally, Octagon’s instructors will address the questions that have been created by the specifications and guidances. Understanding these, and how they have been answered in the field, can help provide a controlled, manageable transition to eCTD.

By the end of 2007, the FDA's Center for Drug Evaluation and Research (CDER) will require all filings to be in the electronic Common Technical Document (eCTD) format or risk receiving a refusal to file letter for their applications or - even worse - losing millions of dollars, find out how Octagon’s experts can help.

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.

 
 
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Written by / Agency / Source: Octagon Research Solutions, Inc.

 
 

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FDANews Audioconference to Feature Thought Leaders from Octagon Research Solutions, Inc.

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Publisher Contact: Jim Graham 
610 535 6500 ext 5655 jgraham[.]octagonresearch.com
 
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