Medical writing in clinical studies

From Planning to the Final Report and Publication

Medical writing plays a crucial role in the conduct of clinical studies. Not only is fulfilling regulatory requirements important, but it also contributes to informing study participants and ensuring transparent communication of study results.

We specialize in drafting documents for clinical studies or advising manufacturers in their preparation. This includes:

• Study synopsis
• Study protocol
• Patient information and informed consent form
• Investigator’s brochure
• Evaluation concept (digital health applications, DiGAs)
• Advertising or flyers
• Study reports (interim and final reports)
• Publication of the study
• Summaries of results or reports

Thanks to our expertise and regular training, we are able to present complex medical and scientific information clearly and precisely in writing. We ensure a comprehensible depiction of the study methodology, results, and the safety and performance of the medical device. We are also experienced in preparing layperson-friendly documents, such as patient information and informed consent forms.

A selection of publications  involving novineon can be found here.