THOMSON SCIENTIFIC UNVEILS THE RESULTS OF ITS 2006 LIQUENT REGULATORY AFFAIRS TRENDS SURVEY
More than 400 Regulatory Professionals Contribute to this Global Insight into Regulatory Trends
Philadelphia, Pennsylvania, USA — June 19th, 2006 — Thomson Scientific, a business of The Thomson Corporation, and global leader in providing regulatory software solutions, information products and related services for the life sciences industry, today unveiled the early findings of its 2006 Liquent Regulatory Affairs Trends Survey. The survey which was conducted by Thomson Scientific in May 2006 gives insight into how pharmaceutical regulatory professionals use technology today and how they plan to harness technology in the future and it is recognised as the premier benchmark of global regulatory submission trends. The survey provides exclusive insight into the emerging and future trends of regulatory product management needs for the life science market.
447 Regulatory Affairs professionals working in Life Sciences companies across the globe participated in this survey. The survey concentrates on four key areas; Technology Usage Trends, including both submission publishing software and other desktop software, Document Management System usage, Regulatory Outsourcing trends, and Regulatory trends including use or future use of the electronic Common Technical Document (eCTD) and HL7 Regulated Product Submission (RPS) standard. The survey addresses the broader regulatory product management needs including registration management, submission project management and product information management both today and in the future.The demographic make-up of the respondent population is similar to previous years with one-third of respondents (29%) representing large pharmaceutical companies (more than $1 billion), other third (31%) representing medium/small pharmaceutical companies and 15% from biotechnology companies. Over half of the respondents are from the United States. The majority of the remaining respondents are from Europe, specifically the UK, Germany and France.
Survey highlights include:
Technology Usage:
- Almost all (92%) of the survey respondents make regulatory submissions; current usage of paper and electronic submissions has increased since 2005.Three-fourths (70%) state that they will still be using both paper and electronic forms of submission in two years.
- Two-thirds (66%) are using submission publishing software, significantly more than in 2005.
- One-fourth (26%) of those respondents not currently using software are very likely to implement electronic submissions software into their process.
Document Management:
- Three-fourths (74%) of respondents currently use a document management system.
- 38% of the 2006 survey respondents plan to upgrade their current version. This is significantly more than in 2005.
Regulatory Trends:
- One-third or more state that their organization plans to adopt Submission Quality Management, an eCTD Viewer and Labelling Management.
- Approximately, one-fifth of respondents report that their organization plans to adopt the HL7's Regulated Product Submission (RPS) format, EVMPD standard, SDTM standard, SPD standard, Commitment/Correspondence Management and a Regulatory Product Team/Executive Dashboard.
- Three-fourths (78%) of respondents plan to migrate to the eCTD.
Jim Nichols is Liquent's Vice President of Product Strategy and Marketing and pioneered this worldwide initiative. “This year's survey has yielded a tremendous response with 447 regulatory professionals taking the time to give us a unique snapshot of their views and insights into regulatory and technology trends. The survey results help us to anticipate and respond to the demands of the life sciences market and contribute directly to our product direction.” Jim added, “This year is no exception and we are delighted to have been ahead of the game in anticipating the likely demand for an eCTD viewer which has been confirmed in the survey with over half (54%) of the respondents reporting that their organization plans to adopt an eCTD viewer in the next two years. Liquent's product plans, which include the development of Liquent InSight® Viewer designed to enable eCTD dissemination and review within a client's environment, is a perfect response to this market demand.”
Full results of the survey, which has attracted extensive interest from publishers and conference organisers, will be available at the end of June. For more information on the survey, its findings and how to secure a copy, please e-mail liquent.info@thomson.com
About Liquent regulatory solutions
Liquent regulatory solutions provides software, information products, and related services for the life sciences industry. These solutions and services help ensure clients meet the strict standards of regulatory authorities across the world helping them achieve quality, accuracy, and data integrity to deliver regulatory reports and submissions reliably and on time. In addition to technology and services, the Liquent IDRAC database service provides the most comprehensive intelligence on the drug and biologics regulatory environment in 38 of the largest markets in the world.
As a result, 48 of the top 50 global life sciences companies rely on Liquent regulatory solutions to stay current with the latest intelligence and to provide the technology and services to compress the regulatory submissions and approval process, improving speed to market, cost control, and productivity, all of which contribute to ensuring patients' and physicians' timely access to new drugs. Over the last decade, more than 5,000 regulatory submissions have been produced using Liquent world-class products and expert services. For more information please visit, www.liquent.com
Thomson Reuters (www.thomsonreuters.com), with 2005 revenues of approximately $8.5 billion, is a global leader in providing integrated information solutions to business and professional customers. Thomson provides value-added information, software tools and applications to more than 20 million users in the fields of law, tax, accounting, financial services, higher education, reference information, corporate e-learning and assessment, scientific research and healthcare. With operational headquarters in Stamford, Conn., Thomson has approximately 40,500 employees and provides services in approximately 130 countries. The Corporation's common shares are listed on the New York and Toronto stock exchanges (NYSE: TOC; TSX: TOC).
Scientific is a business of Thomson Reuters. Its information solutions assist professionals at every stage of research and development—from discovery to analysis to product development and distribution. Thomson scientific information solutions can be found at www.scientific.thomson.com.
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