ISI’s SaaS
Approach to eCTD
Submissions Helps Boehringer
Ingelheim
Meet FDA
Submission Requirements in Record Time
ISI’s
approach to
eCTD
submissions software delivery allowed company to move quickly with a
Software-as-a-Service hosted solution
Eschborn,
Germany
– March 27th,
2008 –
Image Solutions, Inc.
(ISI),
a leading provider of software and services to streamline the drug development
and regulatory approval process, today announced that world-leading global
pharmaceutical group
Boehringer
Ingelheim
has deployed
eCTDXPress
– the company’s flagship solution for managing and reviewing electronic
submissions – via a Software-as-a-Service (SaaS)
hosted model. The process from selection to implementation and validation took
just under eight months.
Based on
Boehringer
Ingelheim’s
decision to procure the software using the
SaaS
model, the company was able to comply with the
electronic Common Technical Document
(eCTD)
format developed by the International Conference on
Harmonisation.
While many regulatory agencies are moving toward the
eCTD-only
format, the United States is the first to require electronic submissions in
eCTD.
As of
January 1st
2008, the U.S. Food and Drug Administration (FDA) requires the
eCTD
format for electronic submissions, applicable for any
pharma
company targeting the U.S. market.
ISI
offers a range of flexible solutions that address this need, comprising the
relevant tools, global authoring templates, outsourced services, and software.
Crucially, this can be ‘purchased’ as a hosted service,
maximising
speed of deployment, minimising
the internal investment needed in infrastructure changes and skilled resources.
Headquartered in
Ingelheim,
Germany,
Boehringer
Ingelheim
develops and produces pharmaceutical products for human and animal health that
are usually submitted for regulatory approval across the globe, with particular
interest in the most important territories Europe, Japan and the USA. The latter
consequently required their electronic submissions activities to be compliant
with the new FDA regulations.
One of the
crucial decision factors in finding the most appropriate software solution was
whether it could be provided on a flexible
SaaS
basis.
Boehringer
Ingelheim
had given itself until December 2007 to successfully implement the new solution,
precluding an in-house system that would require extensive integration and
validation – and an entire team to be assembled to manage and support the
technology.
The project started in April 2007 and was delivered
on time by December 2007. “This was a very impressive collaboration,” says
Gilbert
Kampfner,
Managing Director of
ISI
Europe. “Nobody had to push back the timelines; everything was ready on
schedule. Furthermore, choosing a
SaaS
solution allowed Boehringer
Ingelheim’s
internal support costs to be cut by approximately 40 percent and this resulted
in considerably lower overall costs than a potential in-house solution.”
Since first
deploying
ISI
software for supporting electronic submissions over five years ago,
Boehringer
Ingelheim
has cut at least two weeks from the submissions cycle. For a blockbuster drug
worth 1 billion euros a year, a two-week time-to-market acceleration is worth a
lot.
Boehringer
Ingelheim
confirmed that it has been a very smooth collaboration with a rapid rollout and
the timelines speak for themselves.
Tags:
FDA compliance;
eCTD;
electronic submissions; medical writing; drug development; drug development
technology; pharmaceutical industry; software-as-a-service
(SaaS);
application service provider (ASP).
Suggested Links:
ISI;
Boehringer
Ingelheim;
FDA eCTD
Guidance
About Image Solutions
Founded in 1992, Image Solutions,
Inc (ISI)
is a proven market leader in providing submissions solutions, process services
and consulting to Life Sciences companies as a way to improve clinical and
regulatory processes that bring new medicines to market.
ISI
was among the first professional services firm to deliver electronic submissions
to the industry and since has delivered nearly 1,200 electronic submissions and
750 eCTD
submissions. The company has a 42 percent market share among Top 50 global
pharmaceutical for its flagship submission product,
eCTDXPress.
ISI
is a privately held company with headquarters in Whippany, New Jersey and
operations throughout the U.S., Europe and Asia.
ISI
also remains committed to giving back to society and sharing its success with
others by donating 10 percent of annual net profits to over 20
recognised
charitable organisations.
For more information, visit the company website at
www.imagesolutions.com
Press Contacts:
Lisa Meyer
Director, Global Marketing
973-560-0808 x. 217
lisa.meyer@imagesolutions.com
Carina Birt
PR for ISI Europe
+44 1722 411150
carina@sarumconsultancy.co.uk
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