Many well-known life science companies already rely on the performance of our products and services, so we decided to let them have their say. To this end, we have launched a series of interviews in which we hear from them directly about how they support our customers and what makes working with them so special.  

Join us for the latest part of our series, where we meet eCTDtemplates. eCTDtemplates tells us how it reduces review time for the industry as well as the agency, how its Word Toolbar facilitates document creation, and why it brings more harmony and flexibility into the everyday work of its users.

 

Hello, eCTDtemplates; thank you for joining us! Can you tell us about yourself and what you bring to the table in the world of common technical authoring?
Hello EXTEDO, it is a pleasure to be here today - thank you for inviting me. You know, everybody knows the structure of CTD, but of course, this structure needs to be populated with document content. This is where I step in and help do so.

I see. Could you please describe what you are exactly doing?
Document authoring is time-consuming, and efficiency is key. I support authors in creating compliant and easily readable documents quickly and conveniently.

You also help in reducing review times and streamlining the approval process, both internally and with the regulatory agencies. How do you do that?
Imagine authoring, reading, and reviewing documents, and all of them look different - in font size, in font styles or colors. Wouldn't you need more time to find something within the document?
Imagine all of that harmonized in the same style and structure… This reduces the time you need - for authoring and later for reviewing. Creating this harmony minimizes time and effort for both industry and agency.

Do you also ensure Effortless Compliance while doing so?
Yes, I do, and this is very important as the content needs to be compliant. Official guidelines tell us which document should include what, both globally and regionally. I always refer to these official guidelines for each CTD section. The author does need to read the guidelines, as my template documents already include their requirements. Plus, I am updated twice a year, so if the guidelines change, EXTEDO inserts this in my templates, and I am always up-to-date and compliant.

One important aspect of your functionality is the EXTEDO Word Toolbar. Can you tell us what this is exactly?
Sure, it is a pleasure. Everyone familiar with Microsoft Word knows that there is a ton of functionality, but across different tabs, different context menus… My toolbar is basically a collection of helpful Microsoft Word functionalities relevant to regulatory document authoring. For example, creating and splitting tables, use footnotes or intra-document  hyperlinks as well as updating fields or a symbol group. I have even more included, so the users don't have to switch very often between different tabs and only work in my toolbar.

Another key feature we often hear about regarding EXTEDOpulse now is Auto-Compilation. What does it do for our customers when it comes to working with you?
One of my advantages is that I am already populated with some metadata. It is included with my individual templates and when it comes to publishing the publishing tool in EXTEDOpulse reads my metadata and knows exactly in which section I am belonging based on this information. It can auto-populate the individual templates to the correct CTD section. This saves time and mitigates errors.

You have just mentioned EXTEDOpulse. How do you integrate with other EXTEDO products?
I am very easy to import and maintain in the Document Management Hub as this is typically the area where the users author my individual documents. Here, they can easily do document versioning and can re-use me for many different regions and products. When it comes to publishing, the solution can auto-compile the relevant and effective documents from the Document Management Hub into the submission structure.

So, do I have to use EXTEDO’s Document Management Hub to work with you?
There are certain advantages if you do, but it is definitely not a must. You know, I want to be flexible – also with my friends and my relations. I can also work purely on my own because I am a strong standalone already. I can even work without any DMS.

If people would like to work with you: Where can they find you and is there something they should know before you get started?
Well, they should know that I consist of different region-related packages, e. g. for submissions in the European Union. And for FDA eCTDs, we have another package or one for Brazil... Of course, you can also acquire multiple packages. Another important information: As I like being flexible, I come with a company license. That means everybody on the team can work with me while the costs stay the same.
Please visit me on the EXTEDO website or ask our Account Managers. They know me already, as we have been working together for some years now, and will put you in contact with me. I am looking forward to seeing you!


eCTDtemplates, we thank you for your time!

 

Would you like to meet another one of EXTEDO’s offers?  

Read the interview with the Regulatory Intelligence Module!

 

 

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