Image Solutions Inc. (ISI), a software and services provider to the Life Sciences industry, announced today at the DIA Conference for Electronic Document Management that it has migrated its regulatory product suite into the ISI Solutions Platform built on Microsoft’s .NET Framework, providing companies with one flexible integrated platform to manage, develop, review and publish electronic submissions. The ISI Solutions Platform enables companies to rapidly accommodate changes in business needs and differing regional requirements without the need to invest in costly new IT resources, expanding and scaling as their needs do.
Among the recent changes to regulatory requirements, FDA’s Center for Drug Evaluation and Research recently announced the recall of the 1999 electronic New Drug Application (eNDA), e Abbreviated NDA (eANDA), and Annual Reports for eNDA and eANDA electronic submission guidance documents. These documents will be removed from the electronic submission docket on December 31, 2007. This action was taken to reaffirm FDA’s commitment and preference to the Electronic Common Technical Document (eCTD) format for electronic submissions. Several European agencies have already made the commitment to electronic regulatory submissions. Europe as a whole is targeting 2009 for all regulatory authorities to have the capability to accept eCTDs.
ISI’s Solutions Platform, built on the .NET Framework, supports an interconnected and interoperable set of applications that rapidly connect systems, people and data across the drug development lifecycle to obtain relevant documentation and publish eCTD and CTD compliant submissions. Because of the Platform’s flexibility, the company’s products can be configured to publish a submission in various formats, including paper, eCTD, NeES (Non-eCTD Electronic Submissions) and proposed standards such as RPS (Regulatory Product Submissions).
“There are several drivers for the move to eSubmissions over the next few years,” observed Paul Chung, Senior Vice President of ISI’s Software & Services Operations. “First, of course, are the eCTD standards themselves. In addition, Life Sciences organization’s R&D investments have consistently grown over the last several years. With increased spending on new product introductions, it should have a direct impact on the number of regulatory filings. Companies need to adapt to electronic submissions as quickly as possible to handle such large volumes of documentation that comply with evolving regulatory changes.
“Further, with more and more companies expanding their geographical presence, eCTD should be perceived as a necessity that will support organizations as they reorganize their business processes and implement a planned approach toward managing the transition,” added Chung.
The ISI Solutions Platform provides a critical technology underpinning for the company’s full suite of offerings, including flagship submission products eCTDXPress® and ISIPublisher™ as well as its productivity tools and templates developed to simplify and streamline workflow and extend the reach of the information contained in submission systems. With ISIToolBox® alone, companies have achieved efficiency gains of almost 70% in file preparation time and 75% reduction in submission Quality Assurance time to achieve faster drug market approval. The company’s products, consulting, and process services help organizations navigate new regulations and fill the internal resource gaps while the organization gets up to speed on the requirements – short term on a submission by submission basis, or part of a longer-term initiative.
Game-Changing features and functionality
Fast Response to Regulatory Requirements; Custom Solutions to Change
The ISI Solutions Platform is a flexible foundation that allows client-specific solutions by accommodating changes in business requirements, differing regional regulatory requirements, or a company’s market needs. The Solutions Platform can support any size company with solutions that scale as the business grows or its submissions environment becomes more complex, with no need to implement new systems every time a change occurs.
The ISI Solutions Platform leverages Microsoft’s .NET Framework to seamlessly allow Life Sciences companies interoperability with any system within and outside the company, including Document Management Systems such as EMC Documentum, FCG’s FirstDoc®, Open Text Livelink and Qumas DocCompliance. Through tight integration with these systems, companies are assured that documents authored in the earlier stages of the drug lifecycle can be used at later points in the submission assembly process, thus creating a single, scalable system to manage all regulatory documents, respond to changes, and publish submissions.
A Common Interface: Putting the User First
The ISI Solutions Platform introduces a common user interface that facilitates document viewing, publication structure tree navigation, and access to regulatory repositories to create a flexible set of components that work together and are easy for the end user to use to create publication for any region, compliant with many country-specific regulations. An intuitive user interface can be totally customized to suit preferences, including user-specific layouts and preferences, including regional settings such as local user interface language.
Low Total Cost of Ownership
Rather than creating a single, expensive application with optional features, The ISI Solutions Platform is built on a foundation of components that work together. Each component is a reasonably-priced best-of-breed that works together, rather than an expensive collection of capabilities. The standards-based IT architecture reduces the complexity and cost of typical infrastructure design. There is no need to pay for new systems, further development resources or maintenance costs related to other regulatory products.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc. (imagesolutions.com) 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 more than 600 electronic 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. For more information, please visit the company website.
Editor’s Note: ISI solutions are showcased at the ISI Booth #112 at the DIA EDM Conference. Please contact Lisa Meyer to arrange a discussion with an ISI regulatory or solution experts.