National Harbor, Maryland (February 17, 2010) In the wake of ongoing R&D cuts among biopharmaceutical companies, organizations are looking to maximize commercial opportunities and make more strategic decisions related to their global portfolios. ISI’s newest version of ISIRegTracker™ incorporates new functionality to help life sciences organizations gain a total picture of their global product portfolios for better management of their submissions and marketing authorizations, quicker responsiveness to regulatory authorities and streamlined decision-making. Launched today at the 23rd Annual DIA Conference for Electronic Document Management (EDM), ISIRegTracker version 4.2 (available in April) is a key component of ISI’s Regulatory Information Management offering, a consulting-led solution that addresses an unmet marketplace need for better quality data and more strategic alignment with corporate goals and processes.
The newest release of ISIRegTracker incorporates functionality that enhances overall usability and delivers more reliable intelligence throughout the R&D enterprise for consumption by executive, strategic and operational teams. ISI’s ultimate goal with the latest release is to improve the quality and reliability of the data being entered into the system; to get actionable information into the hands of decision makers and across a broad range of user communities; and to create a common taxonomy for more effective data sharing. For example, ISI has adopted the EDM Reference Model, which provides a taxonomy/metadata reference model that is considered a common starting point for building sustainable, shareable document management repositories.
While the need for portfolio, submission, and registration management is growing in importance due to economic factors, comprehensive Regulatory Information Management is still in its infancy stage. Most companies currently rely on homegrown and often outdated systems and processes, but they are looking to evolve. According to a recent Gens and Associates Inc. industry survey, 88 percent of companies will make changes to their submission management programs in the next two years and 67 percent of those with a home-grown registration tracking systems will look for a third party partner for services and solutions within the next two years. Submission management is one of the core domains within a regulatory tracking system and allows companies to determine the status of submissions and the resources required to manage them.
“Regardless of the approach in how a company currently manages its regulatory information, ISI’s solution will help companies create a strong foundation for more robust intelligence and portfolio decision-making by helping companies consolidate the view of their data,” said Justin Hur, senior director of R&D at ISI. “Through a scalable methodology that blends software and services, actionable data is culled and disseminated throughout the R&D enterprise for consumption by executive, strategic and operational teams.”
For current ISI publishing clients, integrating the Regulatory Solutions Suite with ISIRegTracker provides organizations with a business process that minimizes data entry and maximizes data reusability, thus creating a closed-loop process for submission planning and tracking. As ISIRegTracker is a stand-alone application, those organizations with other publishing solutions will benefit from ISI’s deep understanding of submission processes and how best to gain maximum value from current investments.
Four Elements of Regulatory Information Management
ISI has outlined the four core domains that comprise a regulatory tracking capability and advocates that companies consider solutions that span the following areas:
1. Portfolio Management: Analyze the complete portfolio – at every phase of the development lifecycle – to help formulate a strategic direction for company investments, partnerships, and divestments;
2. Registration Tracking: Track and manage the registration of drug products by market based on a configurable global data model that incorporates standard lexicons;
3. Submission Management: Track current submission milestones and resources across markets, forecast future submission workload by product portfolio, and intelligently predict capacity;
4. Publishing Tracking & Automation: Integrate Regulatory information management solution with existing publishing tools to initiate publishing based on submission status with the added ability to track submissions documents to analyze and compare submission deliverables.
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.
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.
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.
