Safety & Vigilance
Patient safety in focus
The safety of patients and study participants is at the utmost priority.
Comprehensive monitoring and evaluation of medicinal products and medical devices is crucial to identify potential risks in an early stage and to take appropriate measures to ensure patient safety.
We support you with a team of experts to assist you in all aspects. Recording and assessing adverse events, incidents and other safety-relevant aspects as well as complying with reporting obligations in accordance with legal requirements are only a part of our portfolio.
Safety & Vigilance
- Monitoring and evaluation of data in connection with medicinal products and medical devices
- Preparation of safety management plans
- Systematic capture, evaluation and reporting of adverse events
- Signal detection and evaluation
- Screening of scientific literature and systematic data capture regarding safety relevant aspects
- Supporting the evaluation of adverse events and risk assessment
- Preparation of Individual Case Safety Reports (ICSRs) incl. follow-up
- Electronic reporting of safety-relevant events to authorities
- Training and awareness raising regarding patient and drug safety
- Collaboration with experts and expert committees
Winicker Norimed GmbH
Deutschherrnstraße 15-19
90429 Nuremberg
Phone: +49 (0) 911 / 9 26 80 – 0
E-Mail: info@winicker-norimed.com