FFF Enterprises and LifeTree eClinical Awarded Contract for Clinical Trial Management and Distribution of Immune Globulin.TEMECULA, Calif. -- FFF (FreeForm Fabrication) See rapid manufacturing and 3D printing. Enterprises Inc., a multidimensional healthcare corporation based in Temecula, Calif., and LifeTree eClinical, FFF's clinical services division, today announced the company has signed an agreement with OMRIX Biopharmaceuticals, Inc. ("OMRIX") headquartered in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , NY. FFF will provide support of a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of Omr-IgG-am[TM], OMRIX's intravenous immunoglobulin, for the treatment of primary immune deficiency diseases (PIDD PIDD Primary Immune Deficiency Disease PIDD Platform Implementation Difference Document (iSMART) ). Omr-IgG-am is currently marketed outside of the United States. FFF will use LifeTree's e-clinical data capture services suite to manage the Omr-IgG-am study, the purpose of which is to investigate the efficacy, pharmacokinetics, safety and overall tolerability of Omr-IgG-am, and to determine, on the basis of historical data, whether it is equivalent to immune globulin products currently licensed in the United States for the treatment of subjects with PIDD. Upon 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. approval of the biologics license application (BLA BLA abbr. Bachelor of Liberal Arts ) for Omr-IgG-am in the United States, FFF will become the product's exclusive authorized distributor for five years. "We are pleased to be participating in the search for additional therapies for the treatment of primary immune deficiency diseases," said Patrick M. Schmidt, FFF Enterprises president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "With so many physicians and patients reporting problems with access to immune globulin products, this contract could not have come at a better time; It will allow us to showcase our clinical trials management and secure distribution services, while helping our hospital and physician practice customers better serve the patients who rely on this lifesaving therapy. "And, our commitment to channel integrity will ensure that Omr-IgG-am is distributed with the utmost safety and care," Schmidt continued. About FFF Enterprises FFF Enterprises, founded in 1988, is a multidimensional healthcare company, delivering innovative solutions in biopharmaceutical management and distribution, health information management and consumer healthcare services. FFF is the nation's largest supplier of biopharmaceuticals, plasma products, vaccines and clinical trial drugs. Customers of FFF's four divisions include members of the leading U.S. acute care and non-acute care group purchasing organizations, government agencies, pharmaceutical manufacturers, contract research organizations, managed healthcare and consumers. FFF's unique distribution business model has institutionalized in·sti·tu·tion·al·ize tr.v. in·sti·tu·tion·al·ized, in·sti·tu·tion·al·iz·ing, in·sti·tu·tion·al·iz·es 1. a. To make into, treat as, or give the character of an institution to. b. Guaranteed Channel Integrity[TM], which reflects the company's commitment to purchase only from manufacturers and ship only to healthcare providers. This protects products and patients from the risks of counterfeiting, diversionary practices and irresponsible pricing inherent in secondary and gray markets. |
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