RESTON, Va., June 18 /PRNewswire-FirstCall/ -- PRA International , a leading clinical research organization, today announced that its Regulatory Affairs group now offers a fully compliant technology option for sponsors to file electronic common technical documents (eCTD) with regulatory agencies. The move is in preparation for the U.S. Food and Drug Administration’s plan to require all electronic submissions to be in eCTD format by January 1, 2008.
“The United States and several European Union countries accept the CTD in electronic format,” said Cindy Kirk, vice president, Regulatory Affairs at PRA. “Electronic submissions facilitate faster and more efficient regulatory reviews -- potentially shortening the time to approval. With many countries, including Japan, moving to electronic submissions, strategic planning and state-of-the-art technology are keys to success in today’s market.”
PRA’s solution is based on Liquent’s InSight Publisher 3.5, which enables eCTD submissions but also supports paper submissions in countries where still required. InSight Publisher is integrated with Image Solutions Adobe Plug-in ISIToolBox Pharma Edition to provide PRA’s clients a full spectrum of regulatory publishing resources.
“PRA blends technology with an experienced regulatory team to manage and review submissions, ensuring quality, consistency and compliance,” said Kirk. “PRA’s regulatory affairs group is comprised of experts who understand regional regulatory requirements and can assist sponsors in developing integrated regulatory strategies on a global basis.”
PRA provides full application submission preparation and lifecycle submission support as well as smaller publishing projects such as study report publishing, case report form bookmarking and hyperlinking.
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 that depend on 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: the ongoing need for early and late phase drug development services; project cancellations and timing issues; 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; and general business and economic conditions. Events relating to PRA International could differ materially from those anticipated in these forward-looking statements. Although these statements are based upon assumptions company management 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 2,700 employees working from offices in North America, Europe, Latin America, Asia, Australia and Africa. PRA is committed to delivering reliable service, program-level therapeutic expertise and easy global access to knowledge.
To learn more about PRA International, please visit http://www.prainternational.com or call our World Headquarters at +1 (703) 464-6300.
PRA International
CONTACT: Media, John Lewis, Director of Marketing, +1-703-464-6338, orBusiness Inquiries, Cindy Kirk, Vice President, Regulatory Affairs,+1-913-410-2171, both of PRA International
Web site: http://www.prainternational.com/
