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