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San Diego-based biopharmaceutical company adopts flexible
package of regulatory submission products
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Regulatory submissions for various cancer treatments easily
assembled in eCTD format
WHIPPANY, N.J. (Business Wire EON) May 1, 2008 --
Image Solutions, Inc.
(ISI), a leader in providing software and services to streamline the
drug development and regulatory approval process, today announced that NovaRx,
a privately held biopharmaceutical company based in San Diego,
California, has selected its regulatory submission package. The company
has purchased eCTDXPress,
ISI’s flagship electronic submission software,
as well as ISIWriter,
the industry’s most robust set of global
authoring templates for developing submission-ready documents.
“A confluence of factors –
such as strengthening demand and lack of competition from generic drug
makers – are aligning that bode well for the
biopharmaceutical industry and its role in bringing life-changing
therapies to market,” said Paul Chung,
Executive Vice President of Global Software and Service Operations for
ISI. “Sophisticated organizations like NovaRx
know that in order to bring the next lung cancer drug to the people who
need it, they need to make sure they are compliant with an
ever-changing, and increasingly global, regulatory landscape.”
eCTDXPress is ISI’s web-based solution for
compiling and submitting regulatory submissions in the electronic
Common Technical Document (eCTD) format, managing eCTD lifecycles,
and reviewing submissions. eCTDXPress simplifies the task of creating
and assembling eCTDs, of adding and managing hyperlinks, and of
compiling, validating, and verifying the submission. Depending on
business model and deployment strategy, ISI offers various
implementation options for eCTDXPress, including an enterprise or
desktop version or via a Software-as-a-Service hosted model.
While eCTDXPress helps with the end-of-process submission compilation,
ISIWriter is leveraged earlier in the development process, helping to
guide medical writers in creating properly formatted submission-ready
documents that meet the eCTD granularity requirements. Developed by a
team of experienced medical writers, ISIWriter includes more than 200
content templates to cover all required documents for US and EU
submissions, as well as the common portions (modules 2-5) in use
elsewhere in the world.
“The eCTD has very specific requirements with
regard to hyperlinking and bookmarks in the table of contents and in the
submitted documentation, and dedicated publishing solutions help manage
the generation of these because they are designed to conform to the
specifications,” added Paul Chung,. “Without
either knowing the format or having templates as guides through those
steps, the authoring or publishing team’s
workload gets substantially increased.”
“We believe that eCTDXPress is one of the
most robust eCTD publishing programs on the market today,”
said Patricia Creighton, Head of Regulatory Affairs at NovaRx. “Coupled
with ISI’s 15-year, outstanding reputation in
the industry as a pioneer in regulatory submissions, we are confident
that the combination of ISI solutions will enable NovaRx to comply with
the new eCTD standards in future submissions, while putting in place the
foundation to scale over time, depending on development outcomes.”
Tags: FDA compliance; eCTD; regulatory submission publishing;
electronic submissions; medical writing; San Diego; clinical; cancer
vaccine; drug development; drug development technology; pharmaceutical
industry; biotechnology.
Suggested Links: ISI Web
site; NovaRx; FDA
eCTD Guidance
About NovaRx
NovaRx Corporation is a privately held biopharmaceutical company based
in San Diego, California. The company is developing new therapeutic
approaches for treating cancer with its lead indication focused on
non-small cell lung cancer. Given extremely promising results from the
Phase, NovaRx has now ascertained FDA approval to further Lucanix in a
Phase III front-line clinical trial, which will commence in early 2007.
Pending Lucanix Phase III success, the Company also plans to initiate
prophylactic trials in non-small cell lung cancer, as well as to expand
Lucanix into other cancer indications. Other NovaRx pipeline therapies
include for Gionex™ for glioma.
For more information, visit the NovaRx web site at www.novarx.com.
About ISI
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 firms to deliver electronic submissions to the industry and
since has delivered nearly 1,500 electronic submissions and more than
700 eCTD submissions. ISI serves the top 50 pharmaceutical and biotech
organizations as well as the top companies in other regulated industries.
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
recognized charitable organizations. For more information, visit the
company website at www.imagesolutions.com.
Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and
ISIRegTracker are trademarks or registered trademarks of Image
Solutions, Inc. which may be registered in the United States and
internationally. Other brand names may be trademarks or registered
trademarks of others.
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