Accelerate the medical writing process and remove uncertainty.
Regulatory and commercial demands are prompting life sciences companies to find ways to reduce time-consuming but critical processes and to improve collaboration across departments. One particularly time-sensitive yet laborious task is the authoring of documents.
Typically, various scientists will work on a document, and ideally all of their different pieces of information should flow together. But if each author uses his or her own template, the end result is a messy patchwork. Having a template with all the necessary fields and granular elements means time is not wasted on researching guidance or on creating documents from scratch.
The regulatory tools authors need
DXC Writer provides guidance-compliant templates and tools to enhance collaborative efforts and streamline processes to maximize efficiency. Users can access instructions in the body of each section for guidance on what information needs to be included.
Simpler processes are enabled through access to more than 200 content templates for Microsoft Word, which means users aren’t starting from scratch and can simply add content to relevant sections. DXC Writer’s suite of more than 60 tools and styles makes document authoring effortless, allowing users to focus on content rather than document formatting.
Business results
DXC Writer lets companies confidently create submission-ready medical documents that meet compliance requirements. It delivers functionality and flexibility out of the box; however, the tool can also be customized to suit the needs of a company’s in-house style. For example, one midsize pharma company customized the tool to change the numbering format of tables that fall in the appendix, added symbols for list-bullet styles and added table font styles to match its recently adopted style guide.
Pharmaceutical companies are under pressure to meet submission timelines. DXC Writer’s time-saving styling consistencies help clients finalize their documents and meet deadlines. In this industry, many companies work with contract medical/regulatory writers who use Microsoft Word without the benefits of templates and tools. Several customers address this issue by using DXC Writer to reformat all documents with a consistent style.
Attaching DXC Writer to previously written Word documents or PDFs allows easy reformatting that uses consistent styles (margins, section headings, page headers, etc.). If companies have, over time, lost access to their original Word files and have only PDFs available, they can use DXC Writer to address this issue. By converting PDFs to Word and then attaching DXC Writer, users can match the documents to the DXC Writer styles. The predetermined styles save time in setting up Word to format individual documents or batches of documents.
Transforming medical/regulatory writing processes
Let DXC Technology help you overcome the time-consuming and complex tasks involved in distributing, authoring, repairing and publishing your medical documents. DXC offers:
- Combined weight of knowledge. DXC Writer was designed in cooperation with medical writers, giving companies assurance that DXC’s wealth of experience is behind them.
- Depth of capabilities. DXC’s broad range of solutions can help your organization manage complexity, focus on core businesses, collaborate with partners and customers, and improve operations.
- End-to-end support. DXC understands its customers and provides experts with real-world experience. DXC is vendor-independent, delivering solutions that best meet each customer's unique requirements.
- Tool of choice. Most top 10 pharma companies and more than 80 global companies use DXC Writer to streamline the medical writing process.
- Solution-agnostic. DXC Writer works with Office 365, SharePoint and DXC FirstDoc, allowing edits in real time.
Regulatory tools at your fingertips
With DXC Writer, more than 200 content templates can be distributed to users locally, on each user’s computer, shared with users over a server or even stored in DXC’s FirstDoc. And DXC Writer’s 60 tools and styles make it easy to author documents.
The Hyperlink Authoring Tool makes it easier to add and edit any hyperlink. Documents can be easily prepared for publication with tools that simplify activities such as adding tables of content and lists, creating electronic navigation and creating PDF files.
Another important tool is the Validation Checker, which lets users audit and validate the contents of the document in real time, ensuring conformity and consistency with DXC Writer settings and styles. Any inconsistencies can be automatically corrected with repair tools.
DXC Writer was designed by DXC medical writers who understand the pressure placed on their colleagues in the industry to maximize efficiency. By streamlining workflow across all aspects of medical writing, DXC Writer helps organizations reduce regulatory operations costs. The entire process of creating a document is easier with tools that allow users to generate a table of contents, to create a list of figures or a list of appendixes, or to add hyperlinks and create PDFs with bookmarks to mimic headings.
DXC Writer provides the standard electronic Common Technical Document (eCTD) template for all the documents to be authored, ensuring that each component is covered and properly follows guidance recommendations. Sponsors have the comfort of knowing that all their documentation has the same look and feel, even if it is authored by several different people at multiple locations.
With medical writers able to focus their efforts on content rather than document formatting, companies reduce their risk of failing to comply with guidance. DXC Writer’s repair tools also help medical writers to quickly address document inconsistencies, further ensuring that companies stay compliant.
Get started with DXC Writer
Contact us to talk about how to begin your journey to authoring simplicity and improved document compliance.