DitaExchange
Mapping Information with Familiar Tools

According to the 2015 Global Life Sciences Outlook report released by Deloitte, “Aging populations, chronic and lifestyle diseases, emerging-market expansion, and new treatment and technology advances are expected to spur life sciences sector growth in 2015.” Informa, an analytics company, predicts that this growth will be mirrored in life sciences technology sector and will reach $40.8 billion by 2018. According to Informa’s Ovum, “the increase in IT spending will be fueled in large part by the growth in data analysis and related technologies, the acquisition of systems to comply with new regulatory requirements, and increased spending on applications that advance operating efficiency and automation.” This puts ever-mounting pressure on the pharmaceutical and life sciences industry to manufacture and deliver quality products to the market quickly. When dealing with products intended for the healthcare sector, it becomes critical that they pass compliance tests to meet the high industry standards. However, this process is sometimes hindered by bottlenecks in the system including compliance variations that exist between different regions. DitaExchange, a global firm based in Aarhus, Denmark, understands this maxim well.

“Ensuring that the final product meets or exceeds regulatory compliance requirements is a tedious task that needs to be carried out efficiently and without error,” agrees Jim Nichols, Vice President of Life Sciences at DitaExchange. “The struggle to stay both compliant and efficient is a challenge and if managed incorrectly will have a negative impact on our clients that cannot be quantified in some cases.”

Structured Content Management solutions offered by DitaExchange are designed to help clients become more efficient and less error-prone while generating information that goes to regulatory bodies like the FDA. DitaExchange’s Dx4™ solution runs on the SharePoint platform and in the familiar environment of Microsoft Word. It allows authors to create topic-based structured content without the need of knowing XML. This out-of-the box approach is well-received by users and has helped to shrink the concept-to market duration. "Our clients can experience faster reviews from regulatory bodies on products after implementing our solutions,” says Nichols.

The assessments made with organized data were faster, as reviewers—the FDA in this case—could more easily find information they were looking for. In addition, redundancy of data was greatly reduced with proper structuring.

This solution can create an information map, called a DITA Map, of a collection of documents and can indicate the number of topics that needs to be worked on. The solution is also equipped to handle topics that span across multiple maps. “Our clients now have the freedom to create and modify content maps in a familiar interface,” says Nichols. This process enables business users to rapidly create and modify output templates to produce superior quality documents in accordance to guidelines. In addition, the ability to take maps and data from multiple documents and compile them into a single document is a critical feature in creating documents bound for regulatory submissions. And with DxMerger™, the ability to compare two maps and automatically highlight changes is a boon to the user when it comes to making modifications and solving problems. “Having a stellar product is not enough to stay ahead in today’s market. Our clients work in highly-regulated industries that require sharp focus. We deliver value to them by hiring the best in the field,” adds Nichols. DitaExchange is built in collaboration with leaders from the fields of Life Sciences and Pharmaceutical companies to gain a clear understanding of the business environment, product, and customer.

Ensuring that the final product meets or exceeds the compliance requirement is a tedious task that needs to be carried out efficiently and without error

Looking ahead, the company is prepared to harness the power of cloud based delivery. “We can also offer a robust cloud solution and help our clients adapt when they are ready to embrace this type of deployment,” says Nichols. In addition, DitaExchange will be consistently engaging with the industry in finding innovative ideas and introducing them as products for the clients to stay ahead.