Business Services Industry
IT&E International Announces Long-term, Multi-country Contract with Johnson & Johnson's Subsidiary — Cordis Corporation
Business Wire, August 31, 2004
SAN DIEGO -- IT&E International Group (OTCBB:ITER), announced today that it has signed a long-term, multi-country agreement with Cordis Corporation, a Johnson & Johnson (NYSE:JNJ) company, for expanded FDA regulatory compliance services.
The multi-country contract calls for IT&E to validate trial results and provide a variety of other advanced regulatory compliance services for Cordis as it tests new medical devices in anticipation of FDA approval. IT&E will supply these services to Cordis' laboratories in Miami, Puerto Rico and Mexico.
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Cordis Corporation develops and markets devices for circulatory disease management, including stents, balloons, vena cava filters and catheters used in treating cardiovascular disease and related conditions. The company's products are marketed by clinical application through four main divisions: Cordis Cardiology for coronary applications; Cordis Endovascular for all peripheral applications; Cordis Neurovascular for neurological applications; and Biosense Webster for electrophysiology catheters, and three-dimensional navigation and ablation systems
"By the time a promising new medical device or drug discovery comes to the trial phase, many millions of dollars have already been invested in its research and development. Top manufacturers know that every precaution must be taken to ensure a smooth path through the FDA trials process. That is why the biggest names like Cordis and Johnson & Johnson have come to rely on IT&E's expertise to help meet the complex compliance requirements so as to bring their devices and discoveries to market as quickly as possible," comments Kelly Alberts, President/COO of IT&E International.
"This is just one of a growing number of significant contracts our business development team has negotiated in recent months and is a good indication of the standing IT&E has with pharmaceutical and medical devices manufacturers. The upper echelon of these industries know that they can count on our highly experienced professionals to provide unmatched levels of support to ensure proper auditing, full compliance and complete validation services conforming to strict FDA regulations. We've already proven our capabilities to most of the top industry leaders and are making inroads with those we have yet to serve. Our shareholders can expect to see many more names of this caliber turning to IT&E for expanded services in the future as we work to build IT&E into The premier biomedical services provider," says Peter Sollenne, Chief Executive Officer of IT&E International Group.
For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. Today, 5,300 Cordis employees worldwide share a strong commitment to continue the Company's groundbreaking work in the fight against vascular disease.
IT&E (www.iteinternational.com) focuses on providing leading pharmaceutical, biotech and medical device companies with project-based consulting services and Business Process Outsourcing in the areas of FDA Regulatory Affairs, clinical data management, clinical programming, biostatistics and clinical validation. The company, with its talented team of industry veterans with many years of biopharma experience, utilizes the latest tools and procedures to help its clients move quickly and effectively through the FDA approval process. Its services range from providing patients for drug trials, skilled personnel for trials, enterprise software and training to manage data and ensure FDA compliance and validation of new pharmaceutical manufacturing facilities to biostatistics support and analysis, audits, contract research services, data entry and verification services and providing total clinical solutions that take companies completely through Phase IV clinical trials. The company's pharmaceutical, biotech, healthcare and other life science client list includes such well-known companies as Eli-Lilly, Novartis, Pfizer, Bristol-Myers Squibb, Glaxo Smith Kline Abbott, Schering-Plough, Amgen, Baxter, Aventis Pasteur, Wyeth, Genentech, VaxGen and Chiron.
Included in this release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to have been correct. The Company's actual results could differ materially from those anticipated in the forward-looking statements.
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