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 respondents.
-- 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
|SOURCE Thomson Reuters|
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