Our medical writers help you to structure scientific preclinical or clinical data into clear and readable texts in accordance with scientific principles and regulatory requirements. We provide a wide variety of documents and reports throughout the life cycle of a pharmaceutical or medical device. Our team members are highly skilled with previous experience from pharmaceutical development, clinical trials, and academia.
Services include for example:
- Clinical study or investigational reports
- Clinical and investigational protocols
- Clinical evaluation reports for Medtech products
- Investigator’s Brochure (IB)
- Conformity and benefit-risk assessments
- Aggregate periodic safety reporting (PSUR/PBRER, DSUR)
- Preclinical reporting
- Peer-reviewed literature summaries
- Clinical & nonclinical overviews and summaries (CTD module 2)
- Environmental information at fass.se
Contact Maria Santesson for further information.