WorldCare Clinical, Inc. Plays Major Role in Central Image Management for ABRAXANE, a New Class of Protein Bound Particle Chemotherapy for Metastatic Breast Cancer.CAMBRIDGE, Mass. -- Leading Imaging Core Lab Provides Independent Review of Medical Images and Integrates Remote Access Productivity Tool That Enables Regulatory Authorities to Review DICOM (medical, standard) DICOM - (From Digital Imaging and COmmunications in Medicine) A standard developed by ACR-NEMA (American College of Radiology - National Electrical Manufacturer's Association) for communications between medical imaging devices. Images and Clinical Trial Data WorldCare Clinical, Inc., a leading global provider of medical imaging solutions for clinical trials, announced today that it had provided the imaging core laboratory services for the recently FDA-approved drug, ABRAXANE(TM) for Injectable Suspension (paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); protein-bound particles for injectable suspension)(albumin-bound), indicated for metastatic breast cancer. ABRAXANE(TM) was developed by American Bioscience, Inc. (ABI Abi (ā`bī) [short for Abijah], in the Bible, King Hezekiah's mother. (Application Binary Interface) A specification for a specific hardware platform combined with the operating system. ) and manufactured & marketed by American Pharmaceutical Partners, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : APPX APPX Appendix APPX Application eXcellence (4GL software development tool) ). WorldCare Clinical, Inc. was selected by American Bioscience, Inc to manage the review of Computed Tomography (CT) scans, radiographs and bone scintigrams for the ABRAXANE (TM) clinical trial process in collaboration with radiologists at Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world (MGH MGH Massachusetts General Hospital MGH McGraw-Hill Companies MGH Montreal General Hospital (Montreal, Canada) MGH Monumenta Germania Historica MGH May Go Home MGH Minneapolis General Hospital ) in Boston. At the request of ABI and with the concurrence of the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. , technologists at WorldCare Clinical developed a novel solution called the "Worldcare Remote Imaging Solution (WRIS WRIS Wage Record Interchange System )" for the use of FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. radiologists during their review of the image data from the ABRAXANE(TM)clinical trials. In this new solution, all image data remains on a secure server at Worldcare Clinical's Cambridge, Massachusetts headquarters thereby guaranteeing integrity through elimination of the need to copy or transport the image data to the FDA. WorldCare Clinical's pioneering and innovative WRIS technology solution and new more secure approach to image data management provide the company and its clients with a distinct advantage in the ultracompetitive pharmaceutical, biotechnology, medical device and clinical research markets. WorldCare Clinical has extensive experience in processing medical imaging data for such therapeutic areas as oncology, cardiology, neurology and musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles. mus·cu·lo·skel·e·tal adj. Relating to or involving the muscles and the skeleton. diseases. WorldCare Clinical provided the online WRIS solution to reduce the time required for image review and to reduce travel expenses usually associated with the clinical trial process. The ultimate goal is to accelerate time-to-market of investigative therapies. "WorldCare Clinical's contribution to the clinical trial success - and ultimate FDA approval - of ABRAXANE(TM) was invaluable," said Nguyen V. Dat, Ph.D., vice president of clinical research, American Bioscience, Inc. "The implementation of WorldCare Clinical's secure, remote review solution lead to a more efficient and faster review of imaging data. I express my heartfelt gratitude to WorldCare Clinical, and look forward to partnering with the organization again on additional projects." "I am proud and honored to have been part of the team that contributed to the approval of ABRAXANE(TM), a major discovery in the fight against metastatic breast cancer," said Rick Taranto, chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. , WorldCare Clinical, Inc. "In addition to providing world-class medical imaging review, the implementation of a remote solution represents a technological milestone that should continue to accelerate the review of therapies via thorough analysis of imaging data for a multitude of conditions and diseases." "WorldCare Clinical has been entrusted by its clients to provide clinical trial data management solutions that exploit technology to its full potential," stated Shalom Keynan, chief technology officer, WorldCare Clinical, Inc. "It was a great experience for our team to provide an innovative remote review process to the FDA, which I'm confident will lead to faster imaging data review time for clinical trials. I congratulate ABI for its important discovery for the treatment of breast cancer." About WorldCare Clinical, Inc. Founded in 1992, and headquartered in Cambridge, Massachusetts, WorldCare Clinical, Inc. is a wholly-owned subsidiary of WorldCare Limited, a pioneer and leader in the development, commercialization and distribution of global e-health services and solutions. Dedicated to strict adherence and rigid compliance with all government/industry regulations and standards, WorldCare Clinical is a central imaging core lab that specialize in the expert interpretation, measurement, and analysis of medical images as a proven strategy for accelerating clinical trials. From protocol design through data delivery, WorldCare provides timely, reliable, secure and consistent evaluations to leading pharmaceutical, biotechnology, medical device and clinical research organizations worldwide. For additional information, please visit www.worldcareclinical.com. All trademarks mentioned in the above text are the property of the respective holders. |
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