Image Solutions, Inc. Releases ISIWriter™ 1.1 Software With Customizable Feature for Specific Company Requirements

Posted on December 1, 2005 By Corinne Jones News

 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 release, version 1.1 of ISIWriter™ software.

First released in January of 2005, ISIWriter™ was designed for those in pharmaceutical and biotech organizations who are responsible for creating documents required for marketing application submissions, for example, the Common Technical Document (CTD). The CTD is the emerging standard for new drug application submissions worldwide. After its initial release, ISIWriter enjoyed immediate acceptance by biopharmaceutical organizations as the standard for medical writing when seeking compliance with CTD guidance.

ISIWriter 1.1 contains many new, customer-requested features, including 20 totally new templates covering Annual Reports, Informed Consent, Protocol Amendments and Safety Updates. Additionally, instructions in each of the nearly 200 content templates have also been updated. A new “Style Filter” technology included in 1.1 permits the cleaning of unwanted styles from documents and pasted text. Improvements have also been made to the application’s user interface for cleaner control of document options and user preferences, tables of contents, field insertions, and tables and figures.

A newly added “Site Customization” feature permits clients to customize styles, page layouts, headers, footers and confidentiality statements and store them in one location, with the ability to preserve these customizations even with new versions of the content templates.

Joel Finkle, ISI’s Director of Product Strategy and ISIWriters principal developer, acclaimed the latest version and added 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.”

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 in more traditional formats for legacy study reports. 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. “One of the most time-consuming, process-intensive aspects of embracing the CTD initiative is altering documents to meet the new formatting and granularity required by the CTD standard.” said Peggy Boe, ISI’s Director of Medical Writing Services. ISI’s medical writers created all of the content templates, and we use ISIWriter to support our clients who are preparing to submit for regulatory approval. The submission compilation process is much more efficient using ISIWriter™, because it insures that all documents that are part of a submission are guidance compliant.”

ISIWriter™ software provides a Master Template, which 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 and for formatting. These instructions help reduce the need of Medical Writers to constantly consult guidance documents. ISIWriter™ also 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.

by Corinne Jones