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 Assessment Reports (BER)
- Clinical evaluation reports (CER)
- Toxicological evaluations
- Preparation of manuscripts for publications
Customized documentation and scientific dossiers
Medical writing is concerned with, among other things, writing documents, reports and texts that are necessary for a study. The study results are processed so that they can be published. It therefore involves the comprehensible communication and writing down of clinical and scientific information.
It all depends on the author
The author of such texts needs sound study-relevant and medical knowledge in order to meet the numerous requirements and regulations for the publication of study documents and the general requirements for medical writing. In order to be able to guarantee that the publication is up to date medically, a comprehensive literature search is essential in advance, as inferior study presentation could result in criticism or even damage to the study itself. For these reasons, collaboration with medical writing experts is very valuable.
Precise and accurate – we develop and generate tailor-made documentation.
Precision and accuracy define medical writing at Mediconomics. Scientifically sound documents must be accurate and understandable. Our experienced medical writing experts have an eye for detail and accuracy and are members of the European Medical Writers Association (EMWA), which supports their continuing professional development, ensuring that your documents meet the highest scientific and ethical standards. The result is clear and structured documents that eliminate the need for questions and explanations, saving valuable time in the validation and evaluation phase.
Experience and the latest knowledge ensure success
Based on the solid foundation of many successful projects, we can provide you with competent advice and medical writing expertise for your projects in the areas of regulatory affairs, clinical research and pharmacovigilance.
Locations
Maps
contact@mediconomics.com
+49 (0) 511 560 998-0
Call us
And what can we do for you?
Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci
CEO
Headquarters
Hanover
FAQ – frequently asked questions
Medical writing involves writing scientific texts in the medical field or for the pharmaceutical industry. This includes, for example, the creation of documents for clinical studies – from patient information to regulatory documents and specialist information through to study protocols. Medical writing also involves the preparation of study results in the form of abstracts, posters, presentations, specialist medical articles and lay articles.
Medical writing is needed to summarize and present various medical or scientific data in a structured way and to prepare it in a way that is understandable for different target groups. Medical writers work together with doctors, scientists and other experts in the medical field.
Professional medical writing involves complying with regulations, standards and guidelines and ensuring that you are adequately prepared and up to date with the latest scientific findings. The professional medical writer works in a quality-assured environment in a structured manner and has access to diverse specialist expertise. If this is not observed, unsuitable documents can be produced that not only fail to fulfill the intended purpose, but also fail to meet regulatory requirements.
Professional medical writing is offered by service companies 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 as part of research and development and for the approval of new drugs, which have to be prepared according to different and specific requirements.
Medical writing should be outsourced, as it is a complex area that requires extensive expertise. A good service provider helps to create and prepare medical documents appropriately. With sound specialist knowledge, a structured way of working and a quality-assured environment, this ensures that the objective for which a document is created can be achieved – it is then “fit for purpose”.
Medical writing is an Anglicism and describes “medical writing” in German. It is derived from the profession in which scientists or doctors usually 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 required to present medical knowledge in a structured and concise manner in a document.