Service

Ostermann MedWrite is your professional partner for comprehensive writing and editing services in the following areas:

Regulatory documentation

• CTD Modules 2-5 for submission 
• Clinical study reports
• Clinical protocols
• Investigator Brochures
• Patient narratives
• Patient Informed Consent Forms
• Clinical trial results posting (AMNOG webposting, FDAAA results posting)
• Periodic safety reporting (DSUR, PBRER, RMP)
• Signal evaluation
• Benefit risk evaluation

       Being familiar with laboratory practice, I am also open to write or edit preclinical work.

 Scientific publications in peer-reviewed journals; abstracts, poster

• Articles or reviews based on controlled clinical studies, observational studies, conference symposia, status meetings, basic experimental research, or other

 Medical communication for training and marketing

• Educational material for health care professionals, medical field service, and patients

 Translation: English / German, both directions

• Translation of scientific documents in the field of clinical research, medicine and life sciences