PRA International Expands Electronic Publishing Capability to Support Regulatory Submissions
RESTON, Va., June 18 - 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.
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 www.prainternational.com/ or call our World Headquarters at +1 (703) 464-6300.
FCMN Contact: hhuie@frbir.com
Source: PRA International
CONTACT: Media, John Lewis, Director of Marketing, +1-703-464-6338, or Business Inquiries, Cindy Kirk, Vice President, Regulatory Affairs,+1-913-410-2171, both of PRA International
Web site: www.prainternational.com/
