Survey Highlights Trends In eCTD Migration And Submissions Outsourcing And
Provides Insights Into Regulatory Product Management Trends Across North
America And Europe
PHILADELPHIA and LONDON, July 17 /CNW/ -- The Scientific business of
Thomson Reuters today announced the early findings of its 2008 Liquent
Regulatory Affairs Trends Survey. The survey attracted respondents from
across the globe representing small, medium and large pharmaceutical companies
and provides a unique insight into emerging and future trends in regulatory
product management usage and adoption.
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Now in its sixth year and frequently sourced by pharmaceutical journals
and publications across the world, this survey has become the premier
benchmark of global regulatory submission trends offering timely insights into
how pharmaceutical regulatory professionals use technology today and how they
plan to harness technology in the future.
There were 137 Regulatory Affairs professionals working in Life Sciences
companies across the globe who 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).
The demographic make-up of the respondent population is similar to
previous years with almost one third working in large pharmaceutical companies
(32%) and more than a third working in small to medium companies (36%).
Another 10% of respondents work for biotechnology companies. There were
significantly more respondents from Contract Research Organizations (CROs) in
2008 (10%) than in 2007 (4%). 68% of those surveyed are from the United States
and the majority of the remaining respondents are from Europe, with France
(4%), Switzerland (4%), the UK (3%) and Germany (3%) the most highly
Survey highlights include:
-- Almost all (92%) of the survey respondents make regulatory
submissions, a slight increase on 2007 (90%); current use of paper and
electronic submissions has remained the same since 2007.
-- Three-quarters (75%) are using submission publishing software, similar
to 2007 (67%). Approximately one-third (31%) of those respondents not
currently using software are very likely to implement submission publishing
software into their process.
-- As in 2007, the SAFE initiative has not yet taken hold in most
companies surveyed: only 2% of respondents are currently addressing it.
However, there has been a significant increase in the percentage of companies
that are currently using technology to support the FDA Gateway, up to 19% this
year, from 9% in 2007.
Regulatory Outsourcing Trends:
-- 30% of respondents do not outsource any of their regulatory operations.
-- Printing (28%) was the regulatory operation outsourced the most by
-- Eight in ten (83%) of respondents intend to migrate to the eCTD, with
20% of these reporting they will migrate within the next year.
"This year's survey has once again attracted respondents from across the
breadth of the global life sciences industry, with large as well as small to
medium sized companies participating," said Jim Nichols, Liquent's Vice
President of Product Strategy and Marketing, who launched this worldwide
initiative in 2003. "We're particularly excited to see a significant increase
in the numbers of Contract Research Organizations (CROs) replying to our
survey, further diversifying the population sample."
Full results of the survey are available on request at the following
For more information about Liquent regulatory information management
services, please go to:
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