6 oPINIoN
Automated agility boosts use the
of electronic document systems
Driven by the demands of
the electronic common
technical document
U
ntil even fairly recently, document
have plans to take a drug to NDA, firms still need
management systems have been
to produce their documentation in the eCTD
viewed ambivalently by the
format because of pressure from big pharma
pharma industry, seen by many
partners they may want to work with in future.
(eCTD) standard and organisations as an ill-afforded luxury; a
And, although many mid-sized companies
made easier by hosted
nice-to-have rather than a ‘must-have’. Keeping
have limited resources and personnel, solutions
offerings, electronic
offices freer from clutter and enabling some
that can be implemented quickly and at a low
document management
degree of automation, systems have appeared to
is enjoying a renaissance
cost, and with an immediate impact, such as
among mid-sized pharma
offer some solid advantages, yet with a cost and
eCTD-based solutions, have considerable appeal
organisations – and for
integration burden that has been unpalatable to
– especially if they promise a positive knock-on
good reason, says Adam
some. Until now, that is.
effect on other areas of the business too.
Sherlock.
Recent research conducted on behalf of ISI
Traditionally, use of technology for
suggests that a shift is taking place. The research,
time-consuming administration tasks has been
from a series of focus group sessions in late 2007,
limited among mid-tier biopharma organisations,
Poussée par les
explored the current concerns and priorities of
due to a lack of cash flow, internal expertise and
exigences de la norme
mid-size and emerging biotech firms. The groups
forward planning. The move to eCTD adoption
du document technique
were attended by executives from firms in Boston,
commun électronique
has begun to change that, especially as this has
(eCTD) et facilitée par
San Francisco and San Diego in the US – three
been made more palatable now by the growing
les offres hébergées,
high-impact regions in the
availability of affordable
la gestion électronique
biotechnology industry.
and easy-to-implement
des documents connaît
The study’s aim was
software packages.
un regain d’intérêt to establish a better
At the same time,
auprès des sociétés
understanding of emerging
mid-sized firms are
pharmaceutiques de taille
companies’ evolving
beginning to wise up to
moyenne – et il y a de
business models, processes
bonnes raisons à cela,
the strategic advantage of
and strategies, and to
déclare Adam Sherlock.
automating more of their
identify current challenges
activities. The ISI focus
and requirements.
groups found that, while
Das elektronische
The findings suggest
most small and mid-
Dokumentmanagement that attitudes towards size biopharmaceutical
erlebt durch die technology are changing,
companies were still
steigende Nachfrage
under the influence of new
handling most regulatory
nach dem eCTD-Standard
industry requirements
filings on paper, many
für elektronische
and mounting competitive
Dokumente und durch
were now keen to turn that
Hosting-Angebote
pressures. Technology
situation around. Many
unter mittelgroßen
adoption is now happening
had an eye on the future
Pharmaunternehmen
at an accelerated pace,
too, looking for solutions
eine Renaissance. Und
designed to keep partners
“Technology adoption that could be scaled up as
zwar mit gutem Grund, and regulators happy, and,
is now happening at an
their activities grow, and
wie Adam Sherlock zu
as a natural extension, to
as they submit regulatory
berichten weiß.
accelerated pace, designed
drive greater cost-efficiency
into operations.
to keep partners and
filings in more territories.
While regulatory
Certainly, there is
regulators happy, and, as a
forces were clearly
growing demand for natural extension, to drive
driving the change, the
submissions to be made
greater cost-efficiency into impetus to invest was also
using the electronic common
operations.”
encouraging mid-sized
technical document (eCTD)
firms to streamline their
standard. Even in Europe,
Adam Sherlock,
processes and gain control
where the practice is not
Managing Director,
of their documentation, to
mandatory, or in situations
Image Solutions Europe
integrate their activities
where a company does not
more closely, remove
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