Accelerating Clinical Development Through Effective Medical Writing
MATILDE THYE KVEIBORG /
DIRECTOR OF MEDICAL WRITING
What does your department do?
Matilde — The medical writer role is broad, with the key responsibility to design and deliver fit-for-purpose documents that communicate highly complex information clearly and concisely. 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 Standard Operating Procedure 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. And this means that we have some tricks up our sleeve 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 — I would say it is our extensive experience that sets us apart from other Clinical Research Organisations – particularly with the high complexity and strategic document types, and then our great teamwork. We often work with a cross-functional team of experts representing various skill areas. In such a team, the medical writer role is crucial in helping to facilitate document progress, ensuring clarity in messaging and understanding how the different pieces of information interconnect. 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.
TANJA JENSEN /
SENIOR MEDICAL WRITER
At what stage of clinical development is it best to engage in as a medical writer?
Tanja — I would say very early, as it is 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, 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 clients overcome?
Tanja — Excessive length, incomplete content, and especially poor explanation of rationale are the most frequently encountered issues related to document quality. Particularly, poor explanation of the rationale has the greatest impact on document quality according to regulators. As medical writers, we know how to overcome these issues and prepare high-quality documents. Based on extensive experience, we understand what needs to be done and how to accomplish it. We have our tips and tricks to help our clients achieve the approvals they need.
What are the most important things to consider as a medical writer in the early stages of protocol development?
Tanja — It’s all about a long-term strategy involving stakeholders. This entails understanding the end goal, whether it’s a medicinal product or a device. To ensure consistency, medical writers facilitate important discussions and glean insights from stakeholders into comprehensive writing, all while navigating the nuances of their unique language.
