Image Solutions, Inc.’s Release of ISIWriter™ Software for CTD Compliance, Meets with Rapid Acceptance
Image Solutions, Inc., (ISI) a global technology company and leader in providing software solutions and services for electronic regulatory submissions and clinical trials management, announced today the availability of its latest software product ISIWriter.
ISIWriter is designed for pharmaceutical writers who are responsible for creating documents required for drug submissions, specifically, the Common Technical Document (CTD). The CTD is the International Conference on Harmonization’s (ICH) specification that is promoted as the emerging standard for new drug submissions worldwide.
Usually, one of the most time consuming, process-intensive aspects of embracing the CTD is altering documents to the new formatting and granularity of the CTD standard. This process is eased substantially through the use of ISIWriter, with benefits that continue all the way through the submission assembly and publishing process.
ISIWriter enhances the functions and reliability of Microsoft Word through a variety of icon-based tools that make the process of formatting guidance-compliant documents much more efficient. Furthermore, with ISIWriter’s template package, Medical Writers can focus on writing accurate, concise content, while dramatically reducing time typically spent formatting documents. Writers can create text and documents based on current levels of CTD granularity, or study reports in the legacy granularity. This capability helps streamline the process of writing additional documents for the CTD. ISIWriter’s templates provide continuity and consistency in documents written over the span of a drug product’s development all the way to final marketing application.
The software provides a Master Template, that controls the basic look and feel of the documents, an icon-based toolbar (added into Microsoft Word); and 200 Content Templates, (arranged by CTD Module). All of the templates include clear user instructions and suggestions for composing content, as well as for formatting. These instructions help reduce the need of Medical Writers to constantly consult guidance documents.
ISIWriter streamlines many of the complex tasks required to format headers, create Tables of Contents, insert tables, formulas, symbols, or landscape pages, and insures consistent formatting across regulatory submission documents.
Joel Finkle, ISI’s Senior Consultant and ISIWriter’s principal developer, stated that, “Based on over a decade of experience supporting regulatory document processes at other biopharmaceutical companies, my primary objective was to provide our customers with tools to make it easier to use Microsoft Word correctly, rather than incorrectly, and tools that restore document formatting when problems occur.”
ISI’s own Medical Writing group contributed to the content and the “wish list” for all of the ISIWriter functions, to ensure that the software would meet the needs of Medical Writers. ISI’s Medical Writers use ISIWriter themselves, so whether a client uses the software in-house or chooses to let ISI do the writing, documents will be submission-compliant. Peggy Boe, ISI’s Director of Medical Writing, offered that, “ISIWriter is an extremely valuable and unique tool for Medical Writers who are looking to spend more of their writing time on the scientific aspects of the content and less time on frustrating formatting tasks. By placing the writing focus where it belongs, ISIWriter promotes better content and increases a Medical Writer’s productivity.”
ISIWriter is proving to be so valuable that ISI has sold a significant number of pre-release licenses to pharmaceutical clients who saw immediate value during initial demonstrations of the product. One of the first clients to purchase ISIWriter was Pam Larsen, Senior Manager of Regulatory Affairs at Ovation Pharmaceuticals, a privately-held manufacturer of pharmaceutical products located in Deerfield, Illinois. Ms. Larsen stated that “ISIWriter delivered an extremely powerful template package, with 200 CTD document-specific templates that proved to be best suited for Ovations’ ongoing CTD needs.”
About Image Solutions, Inc.
Image Solutions, Inc. (ISI) is a global, privately-held company founded in 1992 and is the global leader in providing software solutions and services for regulatory submissions and clinical data management. ISI’s worldwide clients, the foremost Life Science organizations, deal with mission critical information and rely heavily on ISI technology to meet the strict standards of worldwide regulatory authorities. ISI solutions help achieve quality, accuracy, and data integrity and expeditiously deliver regulatory reports and submissions. ISI’s focus continues to be developing solutions and services that support the varied needs of the world’s leading Pharmaceutical & Biotech companies. Our systems dramatically compress timeframes for regulatory submission and approval, improving speed to market, cost control, and productivity, thereby ensuring patients’ and physicians’ timely access to new drugs. ISI was a pioneer in developing the first eNDA, the first eCTD of an NCE and the first eIND in eCTD format. To date, ISI has assisted its clients with over 400 eSubmissions and over 65 eCTD’s to regulatory agencies worldwide.
ISI relies on its proven regulatory operations expertise and utilizes industry standard PDF, Web and emerging technology tools to serve its clients in the Life Sciences, Legal, Government and other regulated industries. Flagship tools such as CRFTrack®, DocComposer®, eCTDXPress®, ISIPublisher™, and ISIToolBox™, offer clients superior software solutions for enterprises of any size. Additionally, ISI’s staff of experts also provide ISI OneSource™ services specializing in eSubmission and regulatory operations consulting, project management, scanning, assembly, publishing, web hosting, paper to digital conversion, medical writing, and staff augmentation.
ISI World Headquarters are located in Whippany, New Jersey, with west coast offices in San Francisco, California, and satellite offices throughout the United States. ISI International is headquartered in Heidelberg, Germany with additional offices in Frankfurt, Germany and Bristol, United Kingdom. ISI Asia-Pacific supports operations in Seoul, South Korea, and through a partnership with CAC Corporation, ISI also markets its products and services in Japan and the Pacific Rim countries.
