According to a new survey of life sciences regulatory and technology professionals, an overwhelming majority (87 per cent) of respondents see their organisation's use of electronic submissions software increasing, with nearly one-third saying that they believe they will move to a complete electronic submissions system within one to two years.
The survey, carried out by regulatory software solutions supplier Liquent, also found that 70 per cent of respondents' primary interest in a submissions system is creating electronic and paper output indicating that life science processes are still highly dependent on paper.
The 151 respondents represented a cross-section of the industry, with participants primarily from the USA and Europe. Of the respondents, 31 per cent were from medium/small pharmaceutical companies, 24 per cent from large pharmaceutical companies, 16 per cent from biotechnology companies, 13 per cent from the medical device sector, and five per cent from CROs.
The survey queried participants on three specific topics: technology usage trends, submission outsourcing trends, and regulatory trends.
In terms of technology usage, 86.8 per cent see their use of electronic submissions software increasing, with 31 per cent saying that they believe they will move to a complete electronic submissions system within one to two years. Just 4.6 per cent of respondents indicated that they are aelectronic only' in terms of regulatory submissions at this time.
However, while companies are incorporating electronic systems into their processes, many also remain reliant upon paper: 54.3 per cent are using a combination of paper and electronic systems, 40.4 per cent are still fully paper-based, while 4.6 per cent are using a complete electronic system.
As for athe most important benefits delivered by using regulatory publishing solutions' findings were (in order): submission lifecycle management; process improvement; 21 CFR Part 11compliance; ease of use; workflow support.
More than half of respondents 58.3 per cent say use of vendors/services will increase or stay the same.
The overwhelming majority of total respondents are making regulatory submissions (94.7 per cent). Another four per cent plan to make a submission in the near future.
Solutions, which was acquired by Liquent in December 2003. The survey, while not scientifically conducted, provides insight into how regulatory departments use technology and how they plan to harness technology in the future.
