What does your department do?

Matilde Thye Kveiborg: The medical writer role is broad, with the key responsibility to design and deliver fit-for-purpose documents that communicate highly complex information clearly, concisely, and unambiguously. We handle various types of documents, including typical regulatory documentation, such as protocols for clinical studies, clinical study reports, and Investigators’ Brochures. Additionally, we prepare scientific publications and occasionally assist with marketing materials or SOP writing.

All of our team members come from scientific backgrounds – having obtained PhDs, and some even postdoctoral experience. In addition to our strong scientific foundation, we have dedicated many years to gaining insights into what effective communication is when it comes to drug development. This means that we have some tricks up our sleeves that can help accelerate clinical development by optimising the regulatory documents that we send to the authorities.

What does Aixial Group offer that sets you apart?

Matilde Thye Kveiborg: I’d say it is our extensive experience that sets us apart from other CROs, particularly when it comes to highly complex and strategic documents, and then our great teamwork. We often work with a cross-functional team of experts representing various skill areas.

Additionally, medical writers can assist in guiding the sponsor’s flow of thought, mapping out the path to their conclusions. A medical writer can therefore help pave the way towards documentation that is both compliant and concise, while also aiding the reader’s understanding and interpretation of data.

At what stage of clinical development is it best to engage as a medical writer? 

Tanja Jensen: I would say very early, as it’s crucial to consider how the writing will align with downstream documents. With a comprehensive strategy in place, a medical writer can discern how each piece of information connects with subsequent documents where specific questions must be addressed. For instance, when preparing a protocol, there are many advantages to also considering the clinical study report and subsequent scientific publications, e.g., to ensure regulatory compliance and coverage of necessary aspects for publication in high-impact journals.

What are the most common problems you, as a medical writer, help sponsors overcome?

Tanja Jensen: Poor explanation of rationale, excessive length, and incomplete content are the most frequently encountered issues related to document quality, and particularly poor explanation of the rationale has the greatest impact on document quality according to regulators [1]. As medical writers, we know how to overcome these quality issues and prepare high-quality documents.

What are the most important things to consider as a medical writer in the early stages of protocol development?

Tanja Jensen: It’s all about strategy, a long-term strategy involving stakeholders. This involves understanding the end goal, whether it’s a medicinal product or a device. Medical writers facilitate important discussions and glean insights from stakeholders to put that into the protocol navigating the nuances of their unique language to ensure consistency. With that, data integrity will increase.