Conducting post-authorisation studies in more than one country has several advantages:
- Local investigators will have a good understanding of the healthcare system in their country.
- Increases the sample size
- Such studies satisfy the regulatory requirement to conduct PASS or risk minimisation studies in several EU states
- Provides assurance that risk management and risk minimisation are working in a number of member states
The DSRU conducts European network studies across a number of countries. We bring together a number of partner organisations, write the master protocol for the observational study and act as both a partner and network co-ordinator. The study is undertaken using local data sources in each country, following the master protocol as closely as possible. The DSRU team produces a master final report for the study as a whole.
The DSRU will maintain a presence in the EU post-Brexit
Find out more here: https://www.dsru.org/service/european-network-studies-capabilities or get in touch