Medical Writing

Regulatory documents for clinical investigations

We support you in writing all documents required in the clinical research process of a medical device, pharmaceutical, biologic or combination product. Our experts utilise templates and forms to ensure the completeness and regulatory compliance of these numerous documents.

Publications

We write scientific manuscripts and conference presentations. With the target group in mind, we start by evaluating the best strategy to use based on the available data.

Examples of our medical writing services

• Clinical investigation plan/synopsis
• Patient consent documents
• Patient information
• CRFs (case report forms)
• Questionnaires
• Investigator site file (ISF)
• Investigator brochure
• Patient diaries
• Processing of Authorities and Ethics
• Committees checklists
• Registration of clinical studies
• Interim/Final reports
• Publications
• Safety documents
• Marketing materials
• Literature search

Publication services

The publication of study results is becoming increasingly important, both from a purely scientific research point of view and for company and product marketing. It is vital to have accurate and complete published results for your study that adhere to regulations.

We determine the best ways to publish your results to reach your scientific and marketing goals. Our services include:

• Advice on requirements of publications prior to study start
• Advice for the best use of existing data
• Evaluation of statistics
• Creation of diagrams and figures
• Summaries and abstracts
• Posters and congress papers
• Scientific manuscripts
• Consult, search, and determine matching journals and their requirements
• Customize manuscripts to journal requirements
• Submission of manuscripts
• Literature search