Development Safety Update Reports (DSUR)
Clinical Safety
Development Safety Update Reports (DSURs) are key pharmacovigilance documents that provide an annual review of the safety profile of investigational medicinal products during clinical development.
DSURs ensure continuous safety monitoring and regulatory compliance throughout clinical trials.
PVpharm provides expert support in the preparation, review, and submission of DSURs, ensuring ongoing safety monitoring and regulatory compliance during clinical development.
Our services include:
- Preparation of DSURs: in accordance with ICH E2F guidelines and applicable regulatory requirements
- Clinical safety data management: Compilation and analysis of clinical safety data from ongoing studies
- Data analysis: Integration of emerging safety information and relevant literature findings
- Submission of DSUR: Coordination with clinical teams and regulatory authorities for timely submissions via CTIS.
- DSUR content consistency: Ensuring consistency with other safety documents such as Risk Management Plans and Investigator Brochures
