Medical Writing

Medical writing is an important part of clinical trials and necessary for the approval of medical devices. It includes the draft of scientific (e.g. international journal publications), regulatory or study-related documents (e.g. clinical trial study documents) and is always used for systematic literature reviews or clinical evaluations of medical devices.

Generally, medical writing requires a large number of special and subject-relevant qualifications. In addition to an understanding of medical concepts and terminology, knowledge of the relevant framework conditions with regard to the structure and content of specific documents (e.g. CONSORT standard in randomized controlled trials) as well as good writing skills are required.

Furthermore, medical writing professionals must be familiar with the principles of systematic literature reviews (e.g. PRISMA standard) and should have experience with international scientific journals (e.g. manuscript submission or review). They further should be able to present, edit, analyse (see biometrics) or publish research data. An extended knowledge of legal regulatory processes (see obligations to notified bodies) is additionally helpful when writing scientific/ technical/ medical articles.

Due to continuously increasing demands of international scientific journals, rigorous and long review processes and regulatory requirements for the study documents, medical writing requires a considerable expenditure of time from inexperienced authors. In addition, revisions or subsequent claims of documents can lead to significant delays in the process (e.g. for the approval of medical devices). Hence, it is important particularly for time-critical tasks to work with experienced scientific and medical partners.

CCMD would like to support you. With the involvement of our clinical network and our scientific partners, we support you in the preparation of medical texts and publications of all kinds. Whether the preparation of the clinical evaluation report, or publications in national or international medical journals – CCMD is the appropriate partner for you. We can gladly assist you also in administrative activities such as the registration of clinical trials (e.g. at ClinicalTrials.gov) or the submission of manuscripts (e.g. in international peer-reviewed journals).