With our team of experienced scientists we create texts in an accurate and competent manner according to regulatory requirements and international standards. Our expertise includes e.g.:
- Design of protocols, informed consents, benefit and risk assessments
- Preparation / quality check of clinical study reports (CSRs) according to ICH-E3
- Design / quality check of dossiers for benefit assessment according to § 35a SGB-V (AMNOG)
- Preliminary work for scientific publications
