Global top 5 pharma company

Intelligent authoring: This pharma company is reducing time to market and costs using structured content authoring and document automation

“We release five new products to the market per year, and that number is growing. Per new drug application, our scientists spend 800 days on automatable work, i.e. collect, retype, change, insert and format content and data. We needed to speed up these processes and reduce the amount of costly manual work. That’s why we’ve developed Intelligent Authoring”

— Digital Transformation Program Lead


Improve the speed of development with uncompromised quality

This company is among the world’s largest biotech companies. Throughout its more than 125-year history, it has delivered innovative drugs and diagnostic tools to patients and medical professionals. The company’s development portfolio includes dozens of new compounds in various stages of research and trials at locations across continents. Each new product requires a complex process of managing scientific information and reporting data to internal teams and multiple health authorities.


Ensure data and content consistency from database to documents

In order to reduce the time it takes to bring a new product to market, as well as to control costs of maintaining existing products in multiple markets, the company is streamlining the process of creating documents involved in marketing applications and reporting. 

Frequently, scientists and subject matter experts who use word-processing applications manually copy and paste information from systems such as laboratory information management systems — a process that is prone to introducing errors or including outdated data. There is also significant overlap between the data and analysis of the company’s internal reports and the findings that it shares with health authorities.

“It took me about five hours to redo the authoring of this section, considering all the tables and data content which is available. In contrast to this, usually it would take me a minimum of 10 to 15 hours to complete the same work.”

— Medical Writer 


Automate the creation of documents based on XML and data

With Intelligent Authoring, the company is moving away from a library of static document templates and copy-pasted data — towards a system of dynamic components for automating the creation of documents.

When a document is created, an intuitive interface allows authors to include information such as product names, formulation properties and manufacturing details, from backend systems into XML-based components.

Componentized authoring means that authors can reuse content more readily across documents. This reuse may be related to a single compound or across regulatory submissions that require the same format and structure.

Fonto helps to develop new tools for incorporating laboratory data into documents. Authors can adjust queries and retrieve the latest data from their information-management systems—without having to leave the document they’re writing. And Fonto’s editor transforms the resulting tables into content that’s ready for reuse across documents.

Preparing for a digital future

To date, Intelligent Authoring is focussing on creating Word and PDF documents efficiently and in a controlled way, as these are the formats still requested by regulators and authorities. 

At the same time, Intelligent Authoring serves a strategic goal. Globally, driven by both industry as well as various regulators’ initiatives, the expectation is that submissions and reporting will shift gradually from traditional documents towards digital data formats. By basing its internal documentation processes on structured content, this top 5 pharma company has prepared itself for this digital future.

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