Successful new product launches and high customer satisfaction position firm for market leadership.
Framingham, MA, March 2, 2007 – clinivation, Inc. today announced record year-end revenue, growth, and profitability results for 2006.
“We are pleased to have achieved yet another year of record results, growth, and profitability,” said Joseph Kozikowski, M.D., clinivation’s Founder, Chairman, and Chief Executive Officer.
“Our successful new product introductions have positioned clinivation as the global market leader in Market Clearance Management Solutions. We are delivering this Solution across North and South America, Europe, Asia Pacific, and the Middle East, and we have established relationships with regulatory authorities in more than 100 countries. Our complete Market Clearance Management Solution is delivering breakthroughs in operational efficiency, management control, and risk management that legacy systems and consultants will never achieve,” he continued.
Clinical, quality, and design assurance solutions also achieved significant development and growth, with new software releases in several operational areas.
Multinationals Adopt clinivation’s Market Clearance Management Solutio
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Clinivation’s complete Market Clearance Management Solution- comprising regulatory intelligence delivered as a web service, process automation enterprise software, and on-demand expertise consulting- is delivering breakthroughs in operational efficiency that legacy processes and consultants will never achieve.
“Clinivation WorldView is worth its weight in gold. It saves us countless hours we previously spent conducting internal regulatory research to determine exactly what each country’s Health Authority requires for product registrations-And it keeps us informed of the constantly changing regulatory landscape in real time!” said Kay Fuller, Regulatory Affairs Project Manager, Terumo Cardiovascular Systems, Inc., a subsidiary of Terumo Corporation , a global leader in medical devices that has over 7,500 employees in over 70 locations.
“With thousands of products in over 50 countries, I was seeking a system that would allow my department to better manage product information and registrations. Clinivation Global software has been just the thing!” said Barb Law, Regulatory Affairs Manager, Medex, Inc., a subsidiary of Smiths Medical and Smiths Group plc, a global leader in medical devices used during critical and intensive care, surgery, post-operative care that has over 15,000 employees in forty countries. “Information we previously managed through multiple spreadsheets and files is now right at our finger tips in one well-organized system.”
“I would like to communicate how pleased we are with clinivation Global software,” said Tamara Nelson, International Regulatory Affairs Supervisor, Implant Innovation Services, Inc., a subsidiary of Biomet, Inc., a global leader in surgical and nonsurgical products that has operations at over 50 locations and distributes its products in over 100 countries. “Clinivation Global software is very easy to use, and we like the flexibility to customize reports for regulatory and other departments. Furthermore, the support that clinivation has provided has been exceptional.”
Clinivation Global software easily integrates with the ERP systems of multinational enterprises. Clinivation Global xi is fully validated on InterSystems® Ensemble® Integration Technology, a comprehensive integration platform that uniquely incorporates the functionality of an integration server, application server, high performance object database, and a unified development and management environment in a single, seamless product.
“Customer organizations of all sizes are delighted with our clinivation Global’s ease of ERP integration and deployment,” said Roger Mazzella, M.S., Director, Global Sales at clinivation. “Accordingly, we expect triple-digit revenue growth to continue.”
Clinivation Global software automates and controls the management of highly-regulated business processes for worldwide medical device submissions and approvals. Without clinivation Global software, companies are exposed to regulatory and compliance risks that include inaccurate approval reporting, inadequate order quarantine, and other violations of U.S. and international medical device export and import regulations.
“Smart companies understand that compliance with Section 406 of the Sarbanes-Oxley Act requires internal controls for compliance with applicable governmental laws, rules, and regulations. Clinivation Global software mitigates compliance risk by providing executive officers subject to a code of ethics with timely, accurate, available, and controlled regulatory data,” said Richard Morroney, R.A.C., C.Q.A, Vice President, Quality and Regulatory Solutions at clinivation.
