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CEO Chairman Jim Walker of Octagon Research Solutions, Inc., a provider of breakthrough software and services to the life sciences industry, announced that Octagon is partnering with the Clinical Data Standards Interchange Consortium (CDISC) to provide continuing education on electronic data standards to FDA reviewers.
(WAYNE, PA, September 18, 2008) — CEO Chairman Jim Walker <http://www.octagonresearch.com/management-team.html> of Octagon Research Solutions, Inc. <http://www.octagonresearch.com/> , a pioneer and leading provider of breakthrough software and services to the life sciences industry, today announced that Octagon is partnering with the Clinical Data Standards Interchange Consortium (CDISC) to provide continuing education on electronic data standards to FDA reviewers.
The FDA recently awarded CDISC and its member partners (Octagon Research Solutions, Inc., Destiny Corporation and Maximum Likelihood Solutions, Inc.) with a two-year contract to provide electronic data standards training to their regulatory submission reviewers. Octagon will be conducting the training sessions and will develop appropriate training materials to support the curriculum.
“The FDA understands that data standardization is critical to the clinical data lifecycle,” noted Frank Newby, COO, CDISC. “The planned training program demonstrates the agency’s commitment to CDISC data standards but also reflects the agency’s interest in gaining efficiencies across the review process.”
Planned courses include CDISC Basics, Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM) and Advanced Topics of CDISC Standards. Dave Evans, CIO, Octagon Research Solutions, Inc. noted, “Octagon is looking forward to providing this ground-breaking training to the FDA reviewers. Our combined expertise in both CDISC data standards and the electronic Common Technical Document (eCTD) submission format uniquely positions us to make a meaningful contribution to the agency’s understanding of electronic clinical data standards in the context of electronic regulatory submissions.”
Fred Wood, principal consultant and Lead of the Data Standards Consulting Group at Octagon stated, “Octagon team members have had many interactions with FDA representatives via CDISC teams and the CDISC organization as a whole. We see many of the problems the reviewers have with submitted data, and also see many of the issues sponsors have meeting the eCTD Study Data Specifications. This opportunity will give us the ability to help facilitate the bi-directional flow of information between sponsors and reviewers.”
Jim Walker, chairman and CEO, Octagon Research Solutions, Inc. added, “We are pleased to collaborate with CDISC on such an important project. Our extensive experience conducting industry training globally for CDISC positions us well to engage in this effort. We look forward to the opportunity to gain insight into the FDA review process and how CDISC data standards will positively impact it.”
Octagon continues to provide public and private training on CDISC related topics. To learn more about Octagon’s software and service offerings related to CDISC data standards, please visit our website at www.octagonresearch.com or call us at 610.535.6500.
About Octagon Research Solutions, Inc.
Octagon 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. For more information please visit www.octagonresearch.com