OCTAGON RESEARCH SOLUTIONS SELECTED BY GPC BIOTECH AG TO PRODUCE CDISC SDTM COMPLIANT SUBMISSION DATA
KING OF PRUSSIA, PA - February 23, 2005 - Octagon Research Solutions, the leader in the electronic transformation of clinical R&D, today announced that the company was chosen by GPC Biotech AG (Frankfurt Stock Exchange: GPC, TecDAX index; NASDAQ: GPCB), a transatlantic biopharmaceutical company focused on discovering and developing new anticancer drugs, to produce CDISC SDTM compliant submission data for its satraplatin clinical studies.
The Clinical Data Interchange Standards Consortium (CDISC) developed the Study Data Tabulation Model (SDTM) as a standard for submitting study data to health authorities as part of regulatory filings. The US Food and Drug Administration is now accepting data presented in this format as recognized in recent electronic submission guidances. Octagon is a Corporate Sponsor of CDISC and an active participant in various CDISC working groups, including the Submission Data Standards (SDS) team.
Tom Guinter, vice president of clinical data strategies at Octagon and co-lead of the CDISC SDS team commented, "We will be converting data from a number of satraplatin clinical studies for GPC Biotech. We are eager to work with an organization that recognizes the strategic value of implementing CDISC electronic data standards and is willing to be an industry leader in transitioning toward these standards. I am personally very excited to be sharing some of the practical experiences that we have gained developing and implementing the SDTM standard over the last three years."
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.
About GPC Biotech AG
GPC Biotech AG is a biotechnology company discovering and developing new anticancer drugs. The Company's lead product candidate - satraplatin - is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer following successful completion of a Special Protocol Assessment by the U.S. FDA and receipt of a Scientific Advice letter from the European regulatory authority, EMEA. The FDA has also granted fast track designation to satraplatin for this indication. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company's wholly owned U.S. subsidiary has research and development sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company's Web site at www.gpc-biotech.com.
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