CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a pioneer and leading provider of breakthrough software and services to the life sciences industry, today announced that seven of Octagon's thought leaders have been invited to present at key clinical data standards and electronic submission related conferences. Octagon's regulatory and clinical data strategies experts will present during the CDISC 2009 Interchange North America and the 8th Annual Electronic Submission Conference; eCTD: The Adventure Continues where they will share their extensive practical experiences with evolving data and submission standards.
The CDISC 2009 Interchange North America, will be held November 9-13, 2009 at the Marriott Baltimore Waterfront Hotel, Baltimore, Maryland. Octagon presenters include:
• David A. Evans, MS, chief information officer, who will serve as Track Chair for Session 4A, entitled 'CDISC Shared Health and Clinical Research Electronic Library (SHARE).' This session will be held, Wednesday, November 11, 2009, 4:00 - 5:30 pm EST.
• Barry Cohen, MS, senior director, Clinical Data Strategies, who will co-present a session entitled, 'End-to-End, Standards-based, Meta-driven Clinical Data Lifecycle.' This session will be held, Wednesday, November 11, 2009, 4:00 - 5:30 pm EST.
• Lex Jansen, senior consultant, Clinical Data Strategies, who will present a session entitled, 'Converting the Define.xml to a Relational Database to Enable Printing and Validation.' This session will be held, Thursday, November 12, 2009, 10:30 am - 12:30 pm EST.
• Fred Wood, vice president, Data Standards Consulting, who will co-present during the 'Legacy Data Conversion Workshop' to be held Friday, November 13, 2009, 8:30 am - 12:30 pm EST.
The 8th Annual Electronic Submission Conference; eCTD: The Adventure Continues, will be held November 18-19, 2009 at the Westin, San Diego, San Diego, CA. Octagon presenters include:
• Nancy P. Smerkanich, vice president, Global Regulatory Affairs, who will serve as a co-instructor in the pre-conference tutorial, 'INDs in eCTD Format', which will take place on Tuesday, November 17, 2009, 8:30 - 12:00 pm PST.
• Katie Russo, project manager, Regulatory Affairs, who will present a session entitled, 'eCTD GPS - Navigating Around the Potholes of Electronic Submissions' which will take place on Thursday, November 19, 2009, 8:30 am - 10:00 am PST.
• Chris Gutkowski, project manager, Regulatory Affairs, who will present a session entitled, 'Avoiding Pitfalls When Submitting ANDAs in eCTD' which will take place on Thursday, November 19, 2009, 1:30 - 2:30 pm PST.
"We are honored to have Octagon's regulatory and clinical data strategies experts selected to present during these notable industry conferences," stated Jim Walker. "Organizations such as CDISC and DIA (Drug Information Association) have been at the forefront of educating the industry on emerging industry standards. These conferences provide an ideal platform for Octagon's experts to share their practical expertise in an educational environment."
In addition to presenting, Octagon will be exhibiting at Booth #16 at the CDISC Interchange North America and at Booth #20 during the 8th Annual Electronic Submission Conference. Both exhibits will feature product demos and announcements of Octagon's breakthrough service and technology solutions that optimize the complex process from clinical data collection to regulatory submission.
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 Harrow, UK. Octagon's EDC Operations are located in Mountain View, CA.