August 20, 2009 (FinancialWire) — inVentiv Health, Inc. (NASDAQ: VTIV), a provider of commercialization services to the global pharmaceutical and healthcare industries, 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 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.

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