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Why Your Regulatory Writers Need eCTD Authoring Templates

If you’ve heard about eCTD authoring template suites before, but you’re not sure what they do or whether they would be beneficial to your pharmaceutical company or CRO, you’ve come to the right place. Here I will explain what an authoring template suite is, and how it can improve efficiency among your writers and regulatory team.

What is an authoring template suite?

You’re probably familiar with the idea of a Microsoft (MS) Word “template”—that is, a document that has a heading structure and maybe some prompt text or boilerplate to help you get started. If you write regularly, you have probably used something like this. In the regulatory world, there are literally hundreds of different documents that are required for various drug and medical device submissions. Each document has different requirements and recommendations that often change over time.

A good regulatory authoring template suite includes a full set of these document templates, all ready to be populated with your specific information. The template suite may also include a toolbar, which is a set of functionalities collected into buttons in a MS Word ribbon. These buttons simplify many common tasks that are essential in producing consistently formatted, corruption-free documents. Tasks may include the following:

  • Applying styles
  • Creating and formatting tables
  • Inserting cross-references
  • Generating tables of contents and lists of tables

How does a template suite increase efficiency?

A good regulatory template suite contains a large collection of document templates that cover almost any regulatory need. With such a collection, you can choose a template file and start developing your document without having to “reinvent the wheel” each time. An excellent template suite also contains guidance text, which provides advice for populating the document based on the latest regulatory guidance. Templates like these enable you to spend less time setting up your document and more time developing your content. They also help ensure consistency in structure and appearance between similar documents authored by different writers. The presence of relevant, up-to-date guidance text (in one of those excellent templates) also helps to ensure that your documents contain the information that regulatory agencies need, in the format they prefer.

Then there’s the toolbar component. A toolbar can also streamline the document development process by providing buttons that help you perform frequent and important tasks quickly and consistently, whether you are an experienced MS Word user or not. Tasks that would normally take multiple clicks can be done in just one or two. Simplifying critical formatting processes makes them easy to perform even for inexperienced MS Word users. This results in a huge payoff at the publishing stage, because documents that were properly formatted during the writing process don’t have to be reformatted before conversion to PDF, which saves an enormous amount of effort at crunch time.

Why I didn’t think I needed a template suite

I wasn’t always a cheerleader for template suites. A few years ago, the small CRO where I worked was looking to improve efficiencies. With most of the submission documents being written by scientists (many of them new to the regulatory space) rather than professional writers, the Chief Operations Officer saw an opportunity to use a template suite to support and streamline the development of these critical documents. However, his proposal was met with resistance at various levels (including mine). Some argued that the company’s historical collection of submission documents provided sufficient guidance for new writers. If a template was needed, the writers could take an example from the collection of previous documents, strip out everything but the heading structure, and produce a satisfactory template at less cost.

As one of the few medical writers, I doubted the usefulness of a toolbar. I was very handy with most features of MS Word, so I didn’t see a need for a collection of buttons that enabled me to do tasks I already knew how to do. Also, despite my MS Word skills, I was not comfortable with the process of attaching and using a toolbar. I had used one once for a client project. But, I had not received any training, and I never got the full benefit of it. Eventually, due to the cost and concern about lack of compliance among the scientists and writers, the template idea was abandoned.

How I learned the value of an authoring template suite

About a year later, I moved to Synchrogenix, a Certara company, where authoring templates are used widely. For the first time, I learned what a full template suite looks like. Synchrogenix’s suite contained not just heading structures but also an extensive amount of help text that reflected the latest regulatory guidance. This proved useful in many situations.

As for the toolbar, I completely reversed my opinion. The Synchrogenix toolbar was not only helpful for less experienced MS Word users, but also a time-saving tool even for experienced Word users. It enabled us to focus more on writing and less on formatting. What really won me over is the fact that the toolbar helps me perform common tasks more efficiently and consistently. Tasks that normally require numerous clicks can be done with just one click of a button. My personal favorites include the table creation feature, the style buttons, and the table of contents tools.

The training I received from Synchrogenix also made a big difference. This time using a template suite, I received excellent training by someone who knew the functionality backward and forward and took the time to answer my questions.

Give Authoring Templates a Chance

If you’re already using a template suite, you know how they can improve document development and publishing efficiency. If you’re not, give it some consideration. Having a large collection of documents available to you, along with a toolbar, can significantly reduce the time you spend setting up and formatting your documents. This approach also ensures that you and your team are producing the consistent, high‑quality documents regulatory agencies require.

Synchrogenix eCTD Authoring Templates check all the boxes for excellent templates. Because they were created by regulatory writers and editors, you can rest assured that you’re creating submission-ready, compliant, consistent documents the first time, thus saving your team valuable resources. Click here to learn more about Synchrogenix eCTD Authoring Templates.

About the author

By: Lisa Hove

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