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, today announced that the company has completed the conversion of electronic clinical study data to CDISC SDTM format for over 100 studies across 8 therapeutic areas and 2500 domains.
CDISC (Clinical Data Interchange Standards Consortium) developed the SDTM (Study Data Tabulation Model) as a standard format for the submission of electronic clinical study data to regulatory authorities. The U.S. Food and Drug Administration is currently accepting electronic clinical data in this format and has referenced the SDTM as the recommended format for clinical study data in electronic regulatory submissions. Dave Evans, CIO of Octagon Research Solutions, Inc. noted, “We have gained significant experience with the SDTM in the last year. Our team participated in the development and testing of the specification and used that experience to design our processes and apply appropriate technologies. We are now building on these experiences as the foundation for developing Data Standards Governance Models for our clients. This milestone represents an unprecedented level of experience and our unique commitment to electronic standards implementation and governance.”
Jim Walker added, “We believe that our organization has the most experience in the industry in CDISC SDTM conversions and developing practical strategies for implementing the SDTM. Our leadership position is a result of combining our process-centric approach with real-life, practical experience. This continues to be a successful strategy in leading the transformation of the industry toward electronic standards and processes.”
Octagon Research Solutions, Inc. is a Corporate Sponsor of the CDISC organization and the preferred trainer for the CDISC SDTM. Octagon staff continues to participate in CDISC sub-teams focused on the development of additional data standards for analysis data sets, preclinical data and operational data models.
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 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.