Tom Guinter Selected to Receive FDA’S Leveraging/Collaboration Award

May 25, 2005

Applied Clinical Trials

CDISC Submission Data Standards Team Recognized for Creation of SDTM

Wayne, PA -- May 25, 2005 -- Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, announced today that Tom Guinter, vice president of clinical data strategies, is a recipient of the Food and Drug Administration's (FDA) Leveraging/Collaboration Award. The award recognizes the Clinical Data Interchange Standards Consortium (CDISC) Submission Data Standards (SDS) Team for their work in the creation of the Study Data Tabulation Model (SDTM) and accompanying implementation guide.

The SDS Team was formed to define standard metadata models for case report tabulations and analysis datasets submitted to the FDA that will enable agency reviewers to replicate analyses without requiring complex programming. A secondary objective for the team was to develop metadata model usage documentation for relevant data domains applicable to industry. The Study Data Tabulation Model and accompanying Implementation Guide represent the continuous evolution and practical application of the new standard for submission of clinical data.

Jim Walker, president and CEO, Octagon Research Solutions, commented, "We are very proud of Tom's activities and contributions toward the development of CDISC data standards. We view these evolving submission data standards as enablers to greater change within the industry. Octagon and our leadership team are committed to supporting the development and implementation of such standards in order to gain greater efficiencies in the drug development process."

Tom Guinter noted, "The members of the CDISC SDS team have invested countless hours toward this goal. They leveraged their individual experiences, collaborating on all aspects of this data model without regard to personal or individual company preference. The experience of working with a team of individuals so passionate about the issues and so committed to achieving the team goals is incredibly rewarding in and of itself. We are delighted and honored that the team's efforts and achievements were recognized by the agency for this particular award."

The award will be presented to the SDS team at the Commissioner Honor Awards Ceremony on June 10th in Bethesda, MD.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 Wayne, PA, with offices in Boston, MA and Costa Mesa, CA. For more information please visit www.octagonresearch.com.

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