Drug Safety Unit
"It's all about safety"
The Drug Safety Unit has extensive experience in all aspects of national and international drug safety procedures in phase I to phase IV clinical trials and the handling of post-marketing reports. Our drug safety managers can manage all the different stages, from serious adverse event handling to Periodic Safety Update Reports (PSURs) and Annual Safety Reports for health authorities and ethical committees. The Drug Safety Unit has in-depth knowledge of the national regulatory requirements. This helps to ensure that all drug safety related issues such as SAE handling are processed in accordance to our SOPs, adherence to the ICH GCP guidelines, the EU Clinical Trial Directive and local regulations.
The Drug Safety Unit can be an integrated part of other safety units within the pharmaceutical industry or acting as a stand-alone function for R&D companies in absence of this vital support in-house. Drug safety services are provided for national and international clinical trials in all European countries and for a wide range of European, Asian and US pharmaceutical companies. This unit has experience in drug safety handling for all main therapeutic areas, as well as medical devices. The unit is continuously updating and administrating the safety databases of pharmaceutical companies that have taken the strategic decision of out-placing its safety databases.
The Drug Safety Unit can provide the following services:
- Drug safety support for spontaneous post-marketing and clinical trial adverse events
- Receipt, processing and narrative generation of serious adverse experiences, pregnancies and end-points
- MedDRA and other dictionary coding
- Use of ARISg™ safety database for storage of adverse event information
- Periodic safety and report writing (PSURs)
- Notifications to investigators
- Communication and reporting to regulatory authorities, including electronic reporting
- Support of Drug Safety Monitoring Committees (DSMB)
- Medical monitoring
- Medical expert reviews
- Literature search services
- Drug safety guidance and training
The services provided by the Drug Safety Unit can be contracted as a whole or in part and are also available through our Contract Placement Concept.
Medicines Safety between EU and Japan