Wayne, PA-April 24, 2008-Chief Executive Officer and Chairman Jim Walker of Octagon Research Solutions today announced that the company has experienced significant growth in its Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulations Model (SDTM) related business in recent months.

Dave Evans, chief information officer at Octagon, noted, “This massive upswing in interest in CDISC standards is indicative of a strong industry trend toward standardization across the clinical data lifecycle. Companies are realizing the importance of clinical data standards and how they contribute to the reduction of time and cost within the clinical data lifecycle.”

As the primary trainer for CDISC SDTM for human clinical trials, Octagon has trained more than 2000 registrants representing over 200 different organizations and conducted training in 12 countries throughout North America, Europe, and Asia. To date, the company has completed the conversion of electronic clinical study data to CDISC SDTM format for over 150 studies across eight therapeutic areas and 2500 domains.

Octagon’s CDISC-related services include consulting, data conversions, and data standards governance. These offerings will assist clients in their efforts to implement CDISC data standards, particularly the CDISC SDTM, which is the U.S. FDA’s preferred format for receiving clinical data in an electronic regulatory submission. Octagon’s consultants are often engaged to help clients develop transition strategies and manage their implementations. An increased number of these projects include a forward looking, global focus on data standards governance and the longer-term maintenance of clinical data standards. Octagon offers a packaged solution, ViewPoint® for data standards governance that enables clients to manage and control data standards globally throughout the clinical data lifecycle. As clients continue their transition efforts, they still need to address the conversion of legacy data, which Octagon offers in a business process outsourcing model.

“Octagon’s products and services continue to be recognized within the industry because of our willingness to embrace the transition to new clinical data standards,” noted Walker. “We are taking a leadership position in the electronic clinical data standards arena because we believe the implementation of such standards is critical for the integration and streamlining of clinical and regulatory processes.”

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. The company leverages the power of electronic submissions through 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 

News

As Octagon experienced significant growth in its CDISC SDTM related business, leaders in clinical data standardization note increased interest in CDISC standards.