The Life Sciences industry, like any other, is currently under great pressure
Solution to provide electronic content flow from clinical trial to published submission
Eschborn, Germany – March 24th , 2009 – Image Solutions Inc. (ISI) has joined forces with Oracle to make it easier than ever for pharmaceutical companies to manage their electronic document management activities seamlessly across the drug development lifecycle - from clinical trials to published regulatory submission.
ISI, which dominates the market for regulatory submissions solutions, and now a member of the Oracle® PartnerNetwork, has teamed up with Oracle, with its robust, market-leading clinical data management and electronic data capture technologies. Together the partners will provide pharmaceutical companies new efficiencies as these companies strive to bring their information management and publishing activities under tighter control.
By bringing together ISI’s market-leading eCTDXPress solution with Oracle’s highly acclaimed clinical data management and electronic data capture suite, ISI is helping to remove the growing administrative burden facing international Life Sciences organisations as they attempt to accelerate their speed to market with new products.
Recently, the management of drug licence application submissions has become an increasingly onerous task, particularly across Europe, where requirements and deadlines for electronic submissions vary substantially, especially in relation to the eCTD publishing standard. In the US, where patient Case Report Forms (CRF) are included in submissions, it is critical to be able to accurately manage which patients are included, as those CRFs must be sent electronically as part of any eCTD submission to the US FDA.
With the passing of new deadlines for adoption in 2009 and 2010, European Life Sciences organisations must now respond swiftly with defined strategies for managing regulatory submissions activities efficiently and effectively. Yet, ensuring that information is seamlessly captured and managed electronically from clinical trial right through to electronic submission has been difficult to achieve.
“Our new relationship with Oracle is coming at a very exciting time,” commented ISI’s European Managing Director, Adam Sherlock. “The Life Sciences industry, like any other, is currently under great pressure, and organisations that are already overstretched simply don’t have the capacity to add to their administration workload. By extending the electronic flow of information further across the drug development lifecycle, a combined ISI and Oracle solution should offer pharma companies relief from the complexities of data management, while helping ensure greater accuracy, reduced redundancy, enhanced efficiency and a far shorter time to market with new products, across as many countries as they wish to target.”
About Image Solutions, Inc.
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 thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries. 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. Oracle is a registered trademark of Oracle Corporation and/or its affiliates. Other brand names may be trademarks or registered trademarks of others.
About the Oracle PartnerNetwork
Oracle PartnerNetwork is a global business network of more than 20,000 companies who deliver innovative software solutions based on Oracle software. Through access to Oracle’s premier products, education, technical services, marketing and sales support, the Oracle PartnerNetwork program provides partners with the resources they need to be successful in today’s global economy. Oracle partners are able to offer their customers leading-edge solutions backed by Oracle’s position as the world's largest enterprise software company. Partners who are able to demonstrate superior product knowledge, technical expertise and a commitment to doing business with Oracle qualify for the Certified Partner levels. http://oraclepartnernetwork.oracle.com
Carina Birt, Sarum
PR for ISI Europe
+44 1722 411150
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