Webinars, Seminars, Educational Events and Industry Conferences
Introduction to StartingPoint® and eCTD JumpStart™
Join Octagon's expert Process Consultants to learn more about StartingPoint®, Octagon's global eCTD authoring template suite and eCTD JumpStart™, Octagon's collection of documented standards and practices to support electronic submission authoring. This webinar introduces key features and best practices for developing eCTD capabilities through the implementation of document authoring standards, tools and supporting services.
StartingPoint 3.0, the latest version of Octagon’s suite of submission document authoring templates, will also be introduced during this webinar session.
Monday, May 12, 2008, 1-2pm EDT - To register for this webinar, please Click Here
Monday, May 19, 2008, 1-2pm EDT - To register for this webinar, please Click Here
Monday, May 26, 2008, 1-2pm EDT - To register for this webinar, please Click Here
Monday, June 2, 2008, 1-2pm EDT - To register for this webinar, please Click Here
Monday, June 9, 2008, 1-2pm EDT - To register for this webinar, please Click Here
Monday, June 16, 2008, 1-2pm EDT - To register for this webinar, please Click Here
Monday, June 23, 2008, 1-2pm EDT - To register for this webinar, please Click Here
Monday, June 30, 2008, 1-2pm EDT - To register for this webinar, please Click Here
Submission Data: An Overview of Relevant Data Standards
- Are you planning for a submission to the US FDA?
- Do you know what standards are appropriate for your clinical data?
- Are you flustered by acronym mania when it comes to CDISC, CDASH, SDTM and ODM?
If you answered yes to any of these questions, join Octagon and your industry colleagues for a brief overview of clinical data standards followed by a networking reception. Learn what you need to know about submission data standards and how you can support the implementation of these standards within your organization. Learn what questions you need to ask of your CROs to ensure that they are producing compliant deliverables.
As the FDA continues its efforts to standardize electronic submission documents and data, it will become increasingly important to understand the broad concepts and requirements for electronic clinical data standards. Take time now to lay the groundwork so your team can better understand and more quickly realize the benefits of data standardization.
Two convenient locations to choose from! Date: Tuesday, May 13, 2008
Time: 3:30PM to 6:00PM
Place: Sheraton La Jolla - La Jolla, California
To register, click here.
Date: Thursday, May 15, 2008
Time: 3:30PM to 6:00PM
Place: Sheraton Gateway Hotel - Burlingame, California
To register, click here.
Event Agenda :
3:30PM to 5:00PM: Submission Data Seminar
5:00PM to 6:00PM: Cocktail Reception & Giveaway
This seminar is free of charge and will be followed by a networking cocktail reception where a prize drawing will take place for a digital camera. We respectfully request that all attendees register in advance.
About Our Presenter: Dan Crawford is Director of Clinical Data Strategies at Octagon Research Solutions, Inc. Dan has over 17 years of experience in clinical data management and is a frequently requested presenter at industry conferences. He has direct experience in the implementation of clinical data standards and will share his practical expertise in successfully transitioning to clinical data standards.
DIA 44th Annual Meeting
Date: June 22-26, 2008
Location: Boston, Massachusetts , USA
Booth: #630
Track: Information Technology (IT)
Session Title: The Implementation of Biological Sample Management and Biobanking Systems
Session Chair: David A. Evans, Chief Information Officer, Octagon Research Solutions, Inc.
Day & Time: Monday, June 23, 2008 - 3:30PM to 5:00PM
Track: Electronic Regulatory Submissions/Document Management (ERS/DM 2)
Session Title: The eCTD: Lessons Learned and Practical Experience
Session Chair: Patrick J. Thomas, Associate Director, Regulatory Affairs, Octagon Research Solutions, Inc.
Day & Time: Monday, June 23, 2008 - 3:30PM to 5:00PM
Track: Academic Health Centers/Investigative Sites (AHC/IS)
Session Title: Success at the Crossroads: The Intersection of CDISC Standards with Research Site Processes
Speaker: Mary Lenzen, Principal Consultant, Octagon Research Solutions, Inc.
Day & Time: Tuesday, June 24, 2008 - 2:00PM to 3:30PM
Track: Electronic Regulatory Submissions/Document Management (ERS/DM 1)
Session Title: eCTD: What It Is, What It Is Not, and What It Might Be
Speaker: John Aitken, PhD, Managing Director, West Coast Operations, Octagon Research Solutions, Inc.
Day & Time: Wednesday, June 25, 2008 - 8:30AM to 10:00AM
Track: Clinical Data Management (CDM)
Session Title: Practical Applications of CDISC SDTM
Speaker: David A. Evans, Chief Information Officer, Octagon Research Solutions, Inc.
Day & Time: Wednesday, June 25, 2008 - 3:30PM to 5:00PM
Track: Electronic Regulatory Submissions/Document Management (ERS/DM)
Session Title: eCTD: Life-cycle Management (LCM)
Session Chair: Nancy P. Smerkanich, Vice President, Regulatory Affairs, Octagon Research Solutions, Inc.
Day & Time: Thursday, June 26, 2008 - 8:30AM to 10:00AM
Track: Electronic Regulatory Submissions/Document Management (ERS/DM)
Session Title: Global Submission Management
Speaker: Amanda Keller, Senior Regulatory Manager - Europe, Octagon Research Solutions, Limited
Day & Time: Thursday, June 26, 2008 - 10:30AM to 12:00PM
RAPS 2008 Annual Conference and Exhibition
Date: September 14-17, 2008
Location: Boston, Massachusetts, USA
Booth: #405
