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.
WHIPPANY, N.J. (PRWEB) May 1, 2008
"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
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(TM) for glioma.
For more information, visit the NovaRx web site at http://www.novarx.com.
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 http://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.