Thomson Unveils the Results of the 2005 Liquent Regulatory Affairs Trends Survey
Thousands of Regulatory Professionals targeted for this global benchmark in Pharmaceutical regulatory trends
Philadelphia, Pennsylvania, USA -- June 13th, 2005 -- Thomson Scientific & Healthcare, the global leader in providing regulatory software solutions, information products and related services for the life sciences industry, today unveiled the early findings of its 2005 Liquent Regulatory Affairs Trends Survey. This annual survey, which is now in its third year, provides insights and perspective into how regulatory departments use technology and how they plan to harness technology in the future. Thousands of regulatory professionals were targeted to gather input for what is today recognized as the premier benchmark of global regulatory submissions trends. Thomson Scientific & Healthcare is part of The Thomson Corporation (NYSE: TOC; TSX: TOC).
Regulatory Affairs departments ensure the appropriate licensing, marketing & legal compliance of pharmaceutical and medical products and have become of pivotal significance to the successful development and bringing to market of new products. The 2005 survey yielded responses from Europe and North America with over half its respondents from the US and the majority of the remaining from Europe, specifically the UK, France and Germany. The 117 respondents represent large, medium and small pharmaceutical companies and a third of respondents came from medical devices and biotechnology companies. The study 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). This year's survey also addressed the broader regulatory product management needs including registration management, submission project management and product information management both today and in the future.
Survey highlights include:
- Technology Usage
- Almost all (92%) of the survey respondents make regulatory submissions, and three-quarters (76%) of them stated that they will still be using both paper and electronic forms of submission in two years.
- Interestingly only 2% of respondents are addressing the SAFE initiative and almost three-quarters (71%) don't know whether or not they will implement the process.
- 70% of respondents use a document management system compared with only 50% in 2004
- Regulatory Trends
- Three-quarters (76%) of respondents plan to migrate to the eCTD which compares to 58% in the 2004 survey; one-third (32%) of these respondents plan to migrate within 10-18 months compared with 26% in 2004
- A majority of respondents (69%) are aware of the recent changes to 21 CFR Part 11 in 2004, but just one-third (33%) felt that the changes were only somewhat clearly communicated.
Jim Nichols is Liquent's Vice President of Product Strategy and Marketing and spearheaded this worldwide initiative, "We are delighted with the response that we have received from pharmaceutical, biotechnology and medical devices companies who have taken the time to respond to our survey and provide such valuable insight into how their regulatory departments use, and plan to use, technology. We also welcome the extensive interest that we have received from publishers and conference organisers and we look forward to releasing the full results in the next few days."
For more information on the survey, its findings and how to secure a copy, please contact info@liquent.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,
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