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inVentiv Health Launches REMS OfferingSOMERSET, N.J., Aug 19, 2009 (GlobeNewswire via COMTEX) -- inVentiv Health, Inc. (Nasdaq:VTIV), a leading provider of commercialization services to the global pharmaceutical and healthcare industries, today announced it has launched a comprehensive Risk Evaluation and Mitigation Strategy offering for pharmaceutical and biotechnology clients. In an effort to assure safe use of prescription drug products, the FDA now requires pharmaceutical companies to submit a Risk Evaluation and Mitigation Strategy (REMS) for select products to ensure the benefits of the drug outweigh the risks and side effects. Companies that fail to submit a sufficient REMS response may experience approval delays, face significant restrictions in how they are permitted to promote their products, or be denied approval entirely. inVentiv has gathered experts with broad experience in risk management to provide a complete suite of REMS-related services that can be delivered through a single, integrated program. This customizable offering encompasses a full range of capabilities including strategy development, program design, implementation of all program components, and evaluation and measurement. inVentiv is well positioned to support REMS because of its breadth of capabilities and its extensive experience providing risk management services for prescription drug products that have been identified by the FDA as having significant risks, such as opioids. "There is no cookie-cutter approach for REMS," said Terry Herring, President and COO of inVentiv Health. "While all pharmaceutical companies share a common focus on patient safety, each product will have its own strategy based on its unique risk profile. As a result, manufacturers are intently evaluating how best to respond to the FDA's requirements and design a REMS strategy. Because we have managed risk issues for hundreds of different pharma products, inVentiv is uniquely qualified to provide strategic support to clients on REMS issues, and partner with them to implement these programs." inVentiv's REMS offering includes a wide range of programs including safety and pharmacovigilance initiatives; patient registries; education and awareness efforts targeting healthcare providers, patients and pharmacists; and database development and management -- all of which can be coordinated through a single inVentiv representative. Since 2008, the FDA has approved more than 50 REMS programs for pharmaceutical and biotech products, and industry analysis suggests that more REMS programs will be required by the FDA in the coming years. To learn more about inVentiv's REMS offering, please contact Dan Bobear at [email protected] or Steve Cottrell at [email protected]. About inVentiv Health inVentiv Health, Inc. (Nasdaq:VTIV) is an insights-driven global healthcare leader that provides dynamic solutions to deliver customer and patient success. inVentiv delivers its customized clinical, sales, marketing and communications solutions through its four core business segments: inVentiv Clinical, inVentiv Communications, inVentiv Commercial, and inVentiv Patient Outcomes. inVentiv Health's client roster is comprised of more than 350 leading pharmaceutical, biotech, life sciences and healthcare payor companies, including all top 20 global pharmaceutical manufacturers. For more information, visit www.inventivhealth.com. The inVentiv Health, Inc. logo is available at //www.globenewswire.com/newsroom/prs/?pkgid=4942 This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks that may cause inVentiv Health's performance to differ materially. Such risks include, without limitation: changes in trends in the pharmaceutical industry or in pharmaceutical outsourcing; our ability to compete successfully with other services in the market; our ability to maintain large client contracts or to enter into new contracts; and, our ability to operate successfully in new lines of business. Readers of this press release are referred to documents filed from time to time by inVentiv Health, Inc. with the Securities and Exchange Commission for further discussion of these and other factors. This news release was distributed by GlobeNewswire, www.globenewswire.com SOURCE: inVentiv Health, Inc. CONTACT: inVentiv Health, Inc. Investors/Corporate: David Bassin, CFO (732) 537-4804 [email protected] Media: Marcia Frederick (614) 543-6281 [email protected] |