Engage DSRU for your next drug safety study
Why choose DSRU for your next observational post authorisation study?
- Over 120 drug safety studies completed with collaborations on many more.
- All proposals have been accepted by EU regulatory authorities with little or no modifications.
- Led by one of the most experienced experts in Risk Management in Europe, Professor Saad Shakir.
- Team comprises epidemiologists, physicians, pharmacists, biomedical scientists, a data manager and trained coding staff.
- Proven track record of conducting studies to high methodological standards.
- DSRU studies are presented at the major international conferences in pharmacovigilance and pharmacoepidemiology.
A complete package for observational post-authorisation studies
The DSRU has many years’ experience of conducting studies, including cohort studies conducted in primary or secondary care settings, registries, risk minimisation studies, case-control studies, studies based on a number of pharmacoepidemiological databases, and systematic reviews.
We offer a complete study package, including the following activities:
- Consultation and advice on risk management strategy
- Design the study protocol taking account of any specific regulatory requirements
- Write the statistical analysis plan
- Request ethics approval and NHS R&D approval where necessary
- Conduct the study
- Analyse and interpret the study data
- Write interim and final study reports
- Publish the study in high impact peer reviewed scientific journals
- Communicate findings at national and international conferences