DSRU: Experts at Post-authorisation Safety Studies (PASS)

29 April 2019

Here at the DSRU, we are experts at conducting Post-authorisation Safety Studies (PASS) on medicines prescribed in primary, secondary and specialist care.

If your company is nearing the point of submission for European marketing authorisation, please get in touch to find out what sets us apart from other providers.  We have decades of experience, access to NHS prescribers and data and a unique methodology for European network studies. We think you’ll find our fees are very reasonable too, being a non-profit unit.

  • Impeccable track record
  • Dozens of post-authorisation studies completed
  • In-depth understanding of European Pharmacovigilance regulations
  • Flexible, nimble team of clinicians, pharmacists and epidemiologists
  • World class studies at a not-for-profit price

PASS Studies in primary care: we use our Modified Prescription-Event Monitoring (MPEM) methodology and links with 30,000 GPs in England to obtain information from patient medical records. Find out more.

PASS Studies in Hospitals: we use our unique Specialist Cohort Event Monitoring (SCEM) methodology and work with research networks and care teams to obtain information from patient medical records. Find out more.

PASS Studies across a network of European countries: we use our European network study methodology to provide PASS in a number of countries to a common protocol, with the DSRU being the leading partner. The countries will be chosen according to the launch plans for the drug to be studied. Find out more.

PASS Studies in Mental Health: ECHO, our European Consortium for Observational Studies on Mental health products, can conduct PASS studies in the mental health setting across six European countries. ECHO brings together the DSRU’s expertise and track record for observational studies with the experience of a team of consultant psychiatrists from across Europe, who have knowledge of prescribing and health care in their countries, as well as access to national research networks. Find out more.