Medical Writing: Precise and accurate – we develop and generate tailor-made documentation.

  • Our Medical Writing services include:
    • Study designs and protocols
    • Investigational Medicinal Product Dossier (IMPD)
    • Investigator‘s Brochure (IB)
    • Investigational plans
    • Integrated study reports
    • Expert Reports (eCTDs)
    • Biological Evaluation Reports (BER)
    • Clinical Evaluation Reports (CER)
    • Toxicological evaluations
    • Preparation of manuscripts for publications

Our Medical Writing Flyer is available for download.

Tailor-made documentation and scientific dossiers

Medical Writing deals with the creation of documents, reports and texts that are necessary within the course of a study. Study results are processed in order to be able to publish them. This requires comprehensible, coherent communication and documentation of clinical and scientific information.

It all depends on the author

Producing such texts requires well-founded study-relevant and medical knowledge in order to meet the numerous requirements and regulations for the publication of study documents and adhere to the additional guidelines for medical writing. In order to be able to guarantee that the publication is medically up-to-date, an initial comprehensive literature search is indispensable, as criticism or even damage to the study itself could result from incomplete or inaccurate data presentation.

Accurate, comprehensive and easily legible – we develop and generate tailor-made documentation.

Careful precision and concise composition define medical writing at Mediconomics. Science-based documents need to be accurate and easily legible. Our experienced medical writers have an eye for detail and accuracy. They are members of the European Medical Writers Association (EMWA), which supports their continuous professional development, ensuring your documents are delivered to the highest scientific and ethical standards. The results are well-structured and comprehensive documents that clearly address all required aspects, thus saving valuable time during the phase of validation and evaluation.

Experience and the current state of knowledge ensure success

Based on the solid foundation of many successful projects, we have the experience to provide expert advice for your Medical Writing requirements in the fields of Regulatory Affairs, Clinical Research and Pharmacovigilance.

FAQ – frequently asked questions

Medical Writing entails the writing of scientific texts in the medical field or for the pharmaceutical industry. This includes, for example, the preparation of documents for clinical trials – from patient information to regulatory documents and expert knowledge to study protocols. Furthermore, medical writing is used to present the results of studies in the form of abstracts, posters, lectures, medical articles and inlay articles.

Medical writing is employed to compile different medical or scientific data in a structured way, present them, and prepare them in a comprehensible way for different target groups. Medical writers work together with physicians, scientists and other experts in the medical field.

Professional medical writing follows all relevant regulations, standards and guidelines to ensure that all documents are up to date with the latest regulatory and scientific developments. The professional medical writer works in a quality-assured environment in a structured manner and has access to various specialist expertise. Neglecting this can result in inappropriate writing that not only fails to serve its intended purpose but also fails to meet regulatory requirements.

Professional medical writing is offered by service providers or contract research organizations (CROs) such as ours, which have appropriate resources in terms of expertise, access to scientific material, personnel, and quality assurance.

Medical Writing is essential for pharmaceutical companies, as a large number of documents have to be prepared and submitted to the authorities within the scope of research and development as well as for the approval of new drugs. These documents have to be prepared according to different and purpose-specific specifications.

Medical writing should be outsourced because it is a complex area for which it is necessary to have extensive expertise. A professional service provider helps to create and prepare high quality medical documents that meet the regulatory requirements. Sound expertise, a structured way of working and a quality-controlled environment ensures that the document is fit for purpose.

Medical Writing is derived from the profession in which mostly scientists or medical doctors write scientific or medical texts for various purposes.
The term has its origins in the pharmaceutical world and has been established there since it became known that special skills are needed to present medical knowledge in clear, structured and concise documents.