OCTAGON RESEARCH SOLUTIONS RECEIVES CDISC REGISTERED SOLUTIONS PROVIDER DESIGNATION
WAYNE, PA - May 4, 2005 - Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, announced today that it has been named as a Registered Solution Provider by CDISC (Clinical Data Interchange Standards Consortium).
CDISC is an industry standards organization that was formed to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC working group is composed of four different teams, each focusing on the development of a different data model. As Corporate Sponsor r of CDISC, Octagon has taken a leadership role in the SDTM (Study Data Tabulation Model) team and has been actively participating in the testing and development activities of the ODM (Operational Data Model) team. The data standards developed by these teams will have a direct impact of electronic submissions in the US.
"Octagon has been heavily involved in CDISC because of the relevance of CDISC activities to electronic submissions", states Tom Guinter, vice president of clinical data strategies at Octagon and co-lead for the CDISC SDTM team. "We understand the process implications and challenges of implementing new data standards and we are prepared to assist our customers in developing and implementing transition strategies."
"We are pleased to have received the Registered Provider designation from CDISC", notes Jim Walker, president and CEO of Octagon. " This designation represents important credentialing based on the demonstrated expertise that our customers expect. Our commitment to CDISC activities continues to grow as we find new ways to optimize and enable better processes by incorporating such standards throughout an organization."
CDISC Registered Providers must apply for the designation. Applicants must demonstrate expertise in one or more CDISC models, as evidenced in at least one of the following ways:
- Completion of advanced, model-related activities or applications such as controlled testing of CDISC models or demonstrations at a CDISC Connectathon.
- Delivery of commercial products that are based substantially on CDISC Standards, have been recommended and reviewed by at least two CDISC Board or TCC members, and that have a copy of product documentation filed with the CDISC office.
- Active participation on a modeling team for a period of at least one year with at least 75% attendance (as determined by team leaders), combined with a relevant and clearly defined service offering resulting from team participation.
About Octagon Research Solutions, Inc.
Octagon is a 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 cross-functional eSub expertise, a holistic process approach, deep domain knowledge and creative use of technology. Octagon is headquartered in King of Prussia, PA, with an office in Boston, MA. For more information please visit www.octagonresearch.com.
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