inVentiv Health to Open New Clinic in Miami, Florida
Focusing on Patient Access and Recruitment, Site Will Expand inVentiv Health’s Phase I Clinical Services to U.S.
Princeton, NJ – February 12, 2015 – inVentiv Health, a global provider of best-in-class clinical development and comprehensive commercialization services, today announced plans to open a new phase I/IIA clinic in Miami, expanding its phase I clinical services to the U.S.
The clinic will facilitate patient access and help expedite progression to Proof of Concept (PoC) for pharmaceutical and biotech clients who are seeking access to broad patient demographics. The new clinic, which expects to begin running studies in the second half of 2015, will complement inVentiv Health’s existing clinical facility in Quebec City, Canada.
"Phase I clinical research continues to become more complex, requiring rapid recruitment of unique patient and special populations,” said Riaz Bandali, President of the Early Stage business unit for inVentiv Health’s Clinical Division. “The location of the clinic - in the U.S., specifically in Miami - will help provide broad patient access thanks to a large population and diverse demographic. This should enable us to better meet the needs of our clients as they navigate the complex regulatory environment of drug development and approval."
The 65-bed Miami clinic, located in the University of Miami Life Science and Technology Park, will focus on complex studies including first-in-human phase I, phase I-in-patient and other multifaceted phase I trials such as drug-drug interaction, biosimilar, first-to-file and 505b2 trials. Clients also should benefit from inVentiv Health’s innovative approach to clinical trial recruitment, as well as additional capabilities that support the full product life-cycle from early phase development through comprehensive launch and commercialization.
"With inVentiv Health’s phase II-IV clinical business offerings, and our two bioanalytical laboratories in Princeton and Quebec City, our clients should have the information they need to become smarter earlier in the development process, enabling decisions that may improve the design and impact of their confirmatory studies,” said Bandali. “For us, it’s an exciting extension of inVentiv Health’s commitment to accelerating the delivery of our clients’ therapies to market."
About inVentiv Health
inVentiv Health is a global provider of best-in-class clinical development and comprehensive commercialization services, seamlessly linking the capabilities of a leading, global Clinical Research Organization (CRO) with a unique Contract Commercial Organization (CCO). inVentiv Health helps clients improve performance, reduce risk and speed much-needed therapies to market. With 13,000 employees providing services to clients in 70 countries, our global scale and broad expertise make us an attractive strategic partner for companies developing and delivering medicines in a complex operating, regulatory and reimbursement environment. Our clients include more than 550 life sciences companies, including all 20 of the largest biopharmaceutical companies in the world. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. inVentiv Health brings business strategy to science and scientific expertise to business for the better treatment of patients worldwide. For more information, visit http://www.inVentivHealth.com.
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 our performance to differ materially. These forward-looking statements reflect our current views about future events and are subject to risks, uncertainties and assumptions. We wish to caution readers that certain important factors may have affected and could in the future affect our actual results and could cause actual results to differ significantly from those expressed in any forward-looking statement. Such factors include, without limitation: the impact of our substantial level of indebtedness on our ability to generate sufficient cash to fulfill our obligations under our existing debt instruments or our ability to incur additional indebtedness; the impact of customer project delays, cancellations and terminations and our ability to sufficiently increase our revenues and manage expenses and capital expenditures to permit us to fund our operations; the impact of any future acquisitions; the impact of any change in our current credit ratings or the ratings of our debt securities on our relationships with customers, vendors and other third parties; the impact of any additional leverage we may incur on our ratings and the ratings of our debt securities; our ability to continue to comply with the covenants and terms of our debt instruments and to access sufficient capital under our credit agreement or from other sources of debt or equity financing to fund our operations; the impact of any default by any of our credit providers; our ability to accurately forecast costs to be incurred in providing services under fixed price contracts; our ability to accurately forecast insurance claims within our self- insured programs; the potential impact on pharmaceutical manufacturers, including pricing pressures, from healthcare reform initiatives or from changes in the reimbursement policies of third-party payers; our ability to grow our existing client relationships, obtain new clients and cross-sell our services; the potential impact of financial, economic, political and other risks, including interest rate and exchange rate risks, related to conducting business internationally; our ability to successfully operate new lines of business; our ability to manage our infrastructure and resources to support our growth, including through outsourced service providers; our ability to successfully identify new businesses to acquire, conclude acquisition negotiations and integrate the acquired businesses into our operations, and achieve the resulting synergies; any disruptions, impairments, or malfunctions affecting software as well as excessive costs or delays that may adversely impact our continued investment in and development of software; the potential impact of government regulation on us and on our clients; our ability to comply with all applicable laws as well as our ability to successfully adapt to any changes in applicable laws on a timely and cost effective basis; our ability to recruit, motivate and retain qualified personnel; the impact of impairment of goodwill and intangible assets and the factors leading to such impairments; consolidation in the pharmaceutical industry; changes in trends in the healthcare and pharmaceutical industries or in pharmaceutical outsourcing, including initiatives by our clients to perform services we offer internally; our ability to convert backlog into revenue; the potential liability associated with injury to clinical trial participants; the impact of the adoption of certain accounting standards; and our ability to maintain technological advantages in a variety of functional areas, including sales force automation, electronic claims surveillance and patient compliance. Holders of our debt instruments are referred to reports provided to investors from time to time and the offering memoranda provided in connection with the issuance of our notes for further discussion of these risks and other factors.