We are a service provider specializing in medical writing and translations for clinical research, based in Stuhr near Bremen, Germany. Our customers include all leading CROs and sponsors in clinical research on drugs and medical devices.
Quality and adherence to delivery dates are our top priority. All of our medical writers and translators have a scientific education (university degree in human or health sciences) and many years of professional experience in clinical research.
Constant further training in all aspects of clinical research and strict quality control in several review cycles guarantee technical, linguistic and regulatory correctness at all times. Our internal quality assurance processes significantly exceed the requirements of ISO 17100: 2015.
In regard to pricing, we are guided by the individual technical and linguistic complexity of a desired text or source document. We would be happy to make you a non-binding offer.
Translations for Clinical Research
We translate all kinds of documents from clinical research on pharmaceuticals and medical devices. These include, for example:
- Study protocols
- Study protocol synopses
- Informed consent forms
- AE reports (at short notice)
- SAE reports (at short notice)
- Investigator’s brochures
- Pharmacological / toxicological reviews and reports
- Result reports
- Registration documents
- CTDs (Common Technical Documents)
- IMPDs (Investigational Medicinal Product Dossiers)
- SmPCs (Summaries of Product Characteristics)
- Patient brochures
- Packaging leflets
- Operation manuals
- Correspondence with authorities and ethics committees
- Scientific publications
All translators have at least ten years of professional experience in the field of clinical research and a scientific education (university degree in human or health sciences). Constant further training in regard to technical and regulatory aspects of clinical research ensures that all documents always comply with the current requirements in terms of content, form and structure.
Our quality assurance processes exceed the requirements of ISO 17100: 2015. After processing by experts in the relevant field, all documents go through several review cycles and are proofread several times. In addition to the technical and linguistic assessment, quality assurance naturally also includes checking every document for regulatory compliance.
We create all documents needed in clinical research on pharmaceuticals or medical devices for you. This includes, for example, study protocols as well as specialized data collection tools, for instance in the form of questionnaires or patient cards for your clinical study.
Due to the high content-related and formal requirements for these documents, only professional medical writers with more than five years of professional experience and well-founded scientific background (university degree) are working for us. In addition, there are ongoing training courses on technical and regulatory aspects of clinical research to ensure that the documents written on your behalf are always up to date.
We process all documents adapted to the target group and the region so that study participants, investigators or decision-makers are addressed at the correct level of content and language and that country-specific regulatory stipulations are also taken into account at all times.
Our strictly defined quality assurance processes ensure that every document always meets the specified technical, linguistic and regulatory requirements.
We carry out editorial reviews and edits of all texts from clinical research for you. This includes purely linguistic revisions, for example to better adapt a document such as patient information or a scientific journal article to the target group, just as reviewing and revising your documents on a technical and formal level.
The latter includes both scientific aspects such as the statistical review of case number calculations or source research as well as the assessment in regard to compliance with regulatory standards, for example for the module structure in Common Technical Documents (CTDs).
All medical writers working in the editorial field have in-depth scientific university education and at least five years of professional experience in clinical research. Our strict quality assurance includes the review of each document in several review cycles in order to always guarantee technical, linguistic and regulatory correctness.
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