“The documents that are produced by medical writing are key to fulfilling regulatory requirements. And they are also keys to successfully advancing a product’s development.”

What is your job position and how would you define it?

I am Director of Medical Writing meaning that I have the pleasure of heading up our highly competent and dedicated medical writing team. In medical writing, we prepare documents that communicate highly scientific and often complex information in a clear and concise manner.

We are also experts in understanding our target audiences. Some documents are used at the trial site where the clinical studies are conducted to instruct the staff on what to do and which assessment to take. Whereas others are used to send the health authorities to seek approval for new medicines. Each reader group will need a different type of communication.

“Even before the first clinical study is initiated, we draft the first clinical study protocol and the first edition of the investigator’s brochure. And then as the clinical development runs, we contribute with study reports, scientific publications, abstracts, posters, protocol for new clinical studies, investigators brochures updates…”

Matilde Thye Kveiborg, Medical Writing Director

Why is your job position relevant at Aixial Group? 

The documents that are produced by medical writing are key to fulfilling regulatory requirements. And they are also key to successfully advancing a product’s development. We know the regulatory assessors so the people deciding whether new medicine should be approved or not often experience the documents they receive from drug developers are not of good enough quality, this is an area where the medical writing skillset comes into play.

What are some current and future challenges or trends impacting your area of expertise?

One that’s worth noting is a new requirement to prepare layperson summaries. Lay summaries are intended to communicate clinical trial results to people without a scientific background.

And I think first of all it’s a nice gesture to the patients who participate in clinical studies to communicate the trial results to them. Second of all, it is also a good challenge for us to communicate something as complex as the results from a clinical trial with someone like my grandmother or your twelve-year-old nephew in mind.

How is Aixial Group staying at the forefront of the innovation?

One recent example was a project where we used artificial intelligence for a systematic literature review. We knew that the search would yield approximately 6000 articles so the use of an AI tool to help narrow that down to 5 or 6 relevant hits was something that saved a lot of valuable time and was also highly appreciated by the client.