The Scientific Business of Thomson Reuters Publishes Its 2008 Liquent Regulatory Affairs Trends Survey Results

 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 /EMWNews/ -- 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.



    



    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 represented.






    Survey highlights include:



    Technology Usage:

    -- 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

respondents.



    Regulatory Trends:



    -- 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

address: http://www.liquent.com/2008survey/



    For more information about Liquent regulatory information management

services, please go to:

http://www.thomsonreuters.com/products_services/scientific1/liquentinsight

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