Medical Writing

Whether as part of a clinical trial/NIS or as a stand-alone project – our professional medical writing team supports you with broad expertise and many years of experience.

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We offer

  • Professional preparation of study documents
  • Adjustment of the manuscript to the specifications of the respective journal
  • Clarification of the feasibility and the requirements of your diploma/master thesis or dissertation

Our services

We will be glad to support you in preparing:

  • Study protocols (Phase I – IV)
  • Observation plans (NIS / NIS-PASS / PMOS)
  • Clinical investigation plans (CIP) for medical devices
  • Additional study documents, e.g. patient information and informed consent, manuals, etc.
  • Data collection forms, other than the CRF, such as questionnaires or patient diaries
  • Documents for submission to ethics committees or competent authorities
  • Standard operating procedures (SOPs) – tailored to meet your specific needs
  • Interim reports
  • Final reports / Clinical study reports for clinical trials with medicinal products and medical devices
  • Reports for non-interventional studies, questionnaire studies, retrospective data collections and many other research projects
  • Study progress reports
  • Investigator’s Brochure (IB)
  • Lay Summaries

We will be glad to take over the preparation of the following documents:

  • Abstracts
  • Publication manuscripts, such as original articles, short communications or literature reviews
  • Presentations for general public
  • Posters
  • Newsletters for communication with your study team
  • PowerPoint presentations
  • Training material
  • Review of publications

In addition to pure text production, we also offer all-round support for your publication:

  • Review and evaluation of study results with regard to the planned publication and, if necessary, conduct of further statistical analyses
  • Literature research
  • Communication with authors and management of author feedback
  • Preparation of diagrams, illustrations, graphs or graphical abstracts
  • Submission of manuscripts and communication with editors and reviewers
  • Medical translation
  • Classification of the research project (retrospective study, non-interventional study, etc.)
  • Research on related legal and regulatory requirements
  • Preparation of submission documents for ethics committees and authorities as well as communication with them in the course of the project
  • Review of protocols and project plans
  • Advice on numerous other questions that may arise during the first implementation of a research project