Focused on patient safety
Throughout the entire life cycle of a medicinal product/medical device the main focus lies on patient safety. Therefore correct data collection and professional assessments are essential. The process of (pharmaco)vigilance refers to the ongoing and systematic safety surveillance of medicinal products/medical devices in order to detect, assess and take action against any adverse effects.
Our (pharmaco)vigilance service includes, among other things, timely data collection, processing, assessment and reporting of certain adverse events as well as support in the preparation of various safety reports.
Drug Safety in Clinical Trials
We would also be pleased to support you in fulfilling your safety obligations during the conduct of clinical and non-interventional studies.
We will be glad to support you in preparing:
- MedDRA-Coding of adverse events
- MedDRA-Coding of product or procedural deficiencies
- AE / SAE management
- SUSAR-reporting (E2B) to the Ethics Committees / competent authorities
- DSUR preparation (Development Safety Update Report)
- PSUR preparation (Periodic Safety Update Report)
- Collection, processing, review and assessment of individual case reports (ICSR notification (E2B))
- Forwarding of individual case reports, data reconciliation and final report
For (pharmaco)vigilance/safety services in the full service area, we cooperate with partners to complete our services.