Jim Nichols, Vice President, U.S. Operations and Life Sciences
With the rapidly advancing digitization and trends, pharmaceutical companies are looking for solutions that will allow them to make a strategic shift in managing their data. Structured Content Management (SCM) practices that leverage the DITA standard, enable organizations to unlock information currently contained only within specific, complete documents so that it can be used across the organization–without the need to re-author, review or re-approve. SCM moves away from the traditional ways of managing information by allowing individuals to author pieces of content that are then pulled into larger documents as needed at the time of publishing. These pieces of information–called topics–can also be used within other documents as needed, saving considerable time and resources. Dita Exchange simplifies the way organizations create, manage, deliver and re-use important content through SCM solutions built to run on the SharePoint platform.
Many organizations looking to move toward a topic-based authoring solution, wonder how to manage the change in process for their authors. In order to expand the utility of their existing infrastructure–in the cloud or on premise, Dita Exchange utilizes and enhances Microsoft Word so little to no additional software training is required. “As we see cloud as a major player, we built our solutions to be compatible with Office 365, the cloud based version of Microsoft Office,” says Jim Nichols, Vice President, U.S. Operations and Life Sciences, Dita Exchange. Dx4™ from Dita Exchange is a Structured Content Management application integrated within SharePoint in Office 365, enabling clients to create and manage content in a highly structured fashion. By implementing Dx4, clients can standardize their information throughout the business, increasing document quality and decreasing costs as well as review and approval time significantly.
With Dx4, authors create pieces of information called topics that are reassembled using “document maps,” as referred by Nichols.
As we see cloud as a major player, we built our solutions to be compatible with Office 365, the cloud based version of Microsoft Office
Document maps avoid the need to recreate the same content and instead allow managements to reuse the content as needed in their clinical studies. As needs change, new maps are developed by bringing corresponding topics together for publishing, ensuring that documents are consistent and up to date—without having to start over with authoring and approval processes. DxTemplates™ is another add-on feature, introduced in the Dx4 platform. DxTemplates are a robust collection of document and topic templates that have been designed by industry experts to streamline the authoring process and ensure accurate and complete regulatory document output.
To shed light on the efficiency of Dx4, one of Dita Exchange’s clients from life sciences wanted to address challenges in aggregating regulatory intelligence and sharing it across the organization. Additionally, the client had spent long hours on collecting information to draft their newsletter articles. They approached Dita Exchange to find an easier means to explore and manage newsletter. Dx4 enabled the organization to pull the relevant articles for a particular issue of the newsletter. They also created an online searchable knowledge base where all of the articles can go live and be found in real-time using an internet browser and a SharePoint search engine. “Dx4 standardized all the different articles collected from different people, giving a single look and feel to the document,” adds Nichols.
In addition to the single document approach, Dita Exchange is now investing in solutions that will enable more streamlined approach, allowing users collaborate on structured content. Dita Exchange is focused on finding seamless ways of embedding its technology into everyday processes that allow clinical professionals to manage data within documents and keep that information synchronized while ensuring compliance. The company is currently innovating solutions to cater to the European market which will soon be challenged by another regulation—EMA Policy 70.