PRA International, Inc. Lauds Research Showing Clinical Research Organizations Expand Speed And Capacity Of Drug Development Pipeline
RESTON, Va., Jan. 27 /PRNewswire-FirstCall/ -- PRA International , one of the world's leading Clinical Research Organizations (CROs), commends a new study indicating that CROs have increased the speed and efficiency of the pharmaceutical and biotechnology industry's product- development pipeline. The study, conducted by the Tufts Center for the Study of Drug Development, found that CROs provide a growing proportion of the skilled staff and facilities involved in clinical research around the world, and that the realignment has increased the speed and efficiency of drug development efforts while maintaining clinical-trial data quality and high levels of regulatory compliance.
"As one of the few companies in the CRO or pharmaceutical industries with the capability to conduct the truly global, complex studies needed to bring major new drugs to market, we welcome this research that affirms our value proposition," said Bruce Teplitzky, executive vice president of business development at PRA international. "Everyday, we come to work with our Project Assurance commitment in mind: delivering quality projects on time and within budget so that our study sponsors can bring new products to market faster to help people live better lives."
The study was commissioned by the Association of Clinical Research Organizations (ACRO), which represents some of the world's leading CROs. The association wanted to examine the contribution its members make to the pharmaceutical industry's overall development capacity, and assess the impact clinical outsourcing has on development-project performance.
Evidence has been accumulating for some time that CROs are, in effect, expanding development capacity without requiring drug or biotechnology firms to increase the size of their staffs or expand their facilities, said ACRO Executive Director Douglas Peddicord, Ph. D. However, the amount of research into the measurable contributions made by CROs has been limited. "We wanted to document the crucial contribution CROs are making to drug development," Peddicord said. "To answer these questions, ACRO was pleased to sponsor the first independent, third-party examination of why the CRO industry is growing at such a strong rate."
Among the study's key findings were: -- Since 2001, spending by pharmaceutical and biotechnology companies on contract clinical research services has grown 15 percent annually, outpacing the 9 percent annual increase on overall development spending. -- Between 2001 and 2004, headcount among major CROs grew 6 percent annually while project-sponsor headcount remained flat, indicating an increased reliance on CROs by the pharmaceutical industry. -- Drug companies reported that projects with a high reliance on CROs stayed closer to schedule than those making less use of CROs. Typically, projects that relied heavily on CRO participation submitted their data to regulators more than 30 days closer to the projected submission date than projects with less CRO participation. -- Even larger, more complex trials are completed more quickly when they have a high degree of CRO involvement.
To conduct the study, Tufts held a series of wide-ranging interviews with representatives of 31 pharmaceutical and biotechnology companies of varying size. The researchers gathered data on 79 New Drug Application (NDA) and four Biologics License Application (BLA) submissions made between 2000 and 2004. In addition, the researchers, Senior Research Fellow Ken Getz, M.S., MBA, and Research Assistant Laura Faden, collected data from ACRO member companies, including PRA International.
Cautionary Note Regarding Forward-Looking Statements
This news release contains forward-looking statements that are subject to risks and uncertainties relating to PRA International's future financial and business performance, as well as any other predictive statements dependent upon future events or conditions, or that include words such as "expect," "anticipate," "intend," "plan," "believe," "seek," "may," "will," "estimate" or similar expressions of futurity. You should not place undue reliance on any forward-looking statements, which represent the Company's statements only as of the date of this news release and are not intended to give any assurance as to actual future events. Factors that might cause future events to differ include: our ability to continue providing our services effectively, including the quality or accuracy of the data or reports provided and our ability to meet agreed upon schedules; the ability and willingness of our clients to continue to spend on research and development at rates comparable to or greater than historical levels; trends or events affecting the CRO industry and the demand for CRO services; government regulation, including regulatory standards applicable to CRO services; evolving industry standards; and technological changes. Events relating to PRA International could differ materially from those anticipated in these forward-looking statements and general business and economic conditions. Although these statements are based upon assumptions the Company believes to be reasonable based upon available information, they are subject to the foregoing risks and uncertainties as well as those described more fully in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our annual report on Form 10-K. This document can be accessed in the SEC's EDGAR database found at http://www.sec.gov . Please note that PRA International assumes no obligation to update any of the forward-looking statements in this release, except as required by applicable securities laws.
About PRA International
PRA International is one of the world's leading global clinical development organizations, with over 2,400 employees working from offices in North America, Europe, South America, Africa, Australia, and Asia. PRA, an ISO 9001:2000 registered company, delivers services to its clients through a unique approach called Project Assurance(R), which represents the Company's commitment to reliable service delivery, program-level therapeutic expertise, easy, global access to knowledge, and involved senior management.
To learn more about PRA International, please visit http://www.prainternational.com or call our World Headquarters at +1 (703) 464-6300.
About ACRO
The Association of Clinical Research Organizations (ACRO) represents the world's leading clinical research organizations. Its members, which represent 65 to 70 percent of all CRO revenues worldwide, provide specialized services that are integral to the development of drugs, biologics, and medical devices. ACRO advances clinical outsourcing to improve the quality, efficiency, and safety of biomedical research. For more information, visit http://www.acrohealth.org .
PRA InternationalCONTACT: John Lewis, Director-Marketing and Public Relations of PRAInternational, +1-703-464-6338, lewisjohn@praintl.com