By adopting an eCTD article service like the one provided by Reprints Desk, information management professionals can standardize and help ease the load on their counterparts in regulatory affairs in support of this critical process.
Los Angeles, Calif. (PRWEB) April 6, 2009
Reprints Desk, Inc., today released results of a survey of information management professionals who attended a session on the role of information centers and electronic common technical document (eCTD) article services in regulatory submissions that was presented by Ian Palmer, the Head of Marketing at Reprints Desk, during the Special Libraries Association (SLA) Pharmaceutical and Health Technology (P&HT) Spring Meeting in March 2009. Survey findings show that while most managers and teams currently support regulatory affairs divisions within their companies, most currently do not support preparations for the eCTD submissions. Survey respondents indicated plans to explore a more formal role within the next year.
Participants in the SLA P&HT survey represented companies in pharmaceuticals (39%), biotechnology (12%), medical devices (5%), and others. Survey result highlights included:
- Information managers and librarians that worked in teams were much more likely to provide support to divisions other than research and development and regulatory affairs, namely clinical affairs, medical affairs, and legal.
- 100% of participating information managers who work as solo practitioners provide support for regulatory affairs and research and development divisions.
- More than 82% of participating information managers who work within a team report support for regulatory affairs, research and development, plus sales, marketing, and business development.
- Less than 50% of participating information managers who work within a team report specific support for regulatory submissions by regulatory affairs divisions.
- More than 50% of surveyed team and solo information managers are currently very familiar or somewhat familiar the eCTD specification and trends prior to the presentation
- 50% of participating information managers who work within a team and 40% of solo practitioners report that they are very likely or somewhat likely to explore a role in supporting regulatory affairs with eCTD submissions this year.
- Less than 20% of information management professionals report that their current document delivery providers supplied an eCTD article service.
"Regulatory submissions professionals and the companies they represent are under significant pressure to prepare submissions that will be successfully validated and accepted," said Antoinette Azevedo, Founder of e-SubmissionSolutions.com and a world-renowned expert in the tools, techniques, processes and vendors involved in producing eCTDs and the supporting technical infrastructure, including electronic document management systems and submissions publishing outsource services. "By adopting an eCTD article service like the one provided by Reprints Desk, information management professionals can standardize and help ease the load on their counterparts in regulatory affairs in support of this critical process."
The eCTD is a specification designed by the International Conference on Harmonization (ICH), essentially an XML backbone file that provides a common organization structure for standardized submission of regulatory information to worldwide health authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). The FDA has mandated that electronic submissions be in eCTD format since 2008, the EMEA has outlined an implementation strategy that requires the use of the eCTD format for all drug and biologic electronic submissions beginning in 2010, and many other countries worldwide have committed to similar implementation initiatives.
Reprints Desk surveyed a cross-section of information management professionals at the Special Libraries Association (SLA) Pharmaceutical and Health Technology (P&HT) Spring Meeting in Napa, California, on March 24, 2009. The survey was conducted using electronic handheld devices to capture and aggregate anonymous audience responses to questions posed by the presenter, Ian Palmer, Head of Marketing at Reprints Desk. Valid responses were received from 41 session attendees. For a complete presentation of results, contact Reprints Desk or download the survey results and presentation at scribd.com online at http://b.tinyurl.com/ectd-survey.
Reprints Desk, ranked first overall and in every category in the 2008 Document Delivery Best Practices and Vendor Scorecard by research and advisory firm Outsell, Inc., and became the first document delivery provider to offer an eCTD article service in July 2007. Reprints Desk provides content workflow solutions and end user tools to help customers in Life Sciences and other research-intensive industries effectively use peer-reviewed literature in research, regulatory submissions, and product promotions.
About Reprints Desk ®
Reprints Desk, Inc. (http://www.reprintsdesk.com)], is a content technology and services company that simplifies how healthcare companies and other enterprises procure, manage and share scientific journal articles and other copyright-protected content. The company's workflow solutions and end user tools help customers effectively use peer-reviewed literature in product promotions, regulatory submissions, and research. A channel supplier for more than 100 scientific, technical, and medical (STM) publishers, Reprints Desk currently serves more than half of the world's Top-50 pharmaceutical companies and earned the #1 ranking in the 2008 Document Delivery Vendor Scorecard by Outsell, Inc. Reprints Desk is a Derycz Scientific, Inc., company. For more information about Reprints Desk, contact Ian Palmer at +1 (707) 658-1931.