Importance of good writing quality
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.
Due to the constantly increasing requirements for study documents of all kinds (concerning form and content), the professional preparation before study start is becoming more and more a decisive factor. Documents that are not only accurate and correct, but also clearly structured, facilitate cooperation with authorities, ethics committees, study sites and patients.
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
The work with study participants often represents a special challenge. If required, we also provide patient information and informed consent forms or patient diaries in “simple language” according to current guidelines in order to avoid communication problems or misunderstandings. Through our cooperation with certified translation service providers, documents for study participants can be prepared in all common languages.
Compliance of your manuscript with the specifications of the respective journal guarantees the best possible acceptance of your publication.
Scientific and medical texts/documents must convince in terms of content, language and structure, and therefore a structured way of working, a broad background knowledge as well as a high level of linguistic competence is required during their preparation.
We will be glad to take over the preparation of the following documents:
- Publication manuscripts, such as original articles, short communications or literature reviews
- Presentations for general public
- 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
We also offer our support in the review or revision of publications, which are at an advanced stage of preparation.
- Matera MG et al., Aclidinium bromide inhalation powder for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease including chronic bronchitis and emphysema. Expert Rev Clin Pharmacol. 2016 Jun;9(6):771-7.
- Zweiker R. et al, Ranolazine: impact on quality of life in patients with stable angina pectoris, results from an observational study in Austria – the ARETHA AT study. Wien Klin Wochenschr. 2019 Apr;131(7-8):165-173.
- Sator P., Safety and tolerability of adalimumab for the treatment of psoriasis: a review summarizing 15 years of real-life experience. Ther Adv Chronic Dis. 2018 Aug; 9(8): 147–158.
Our experienced experts will be pleased to check the feasibility and the requirements of your diploma/master/doctoral thesis and can help you with the following questions:
- 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
We would also be happy to provide support for supervisors in order to jointly develop strategies on how students can be best integrated into your research!