Overview
At the DSRU, we are experts in conducting studies using a range of methods. Scroll through the menu below to discover how we can help you.
- 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.
Types of Study
As well as the studies shown below the
DSRU has many more on offer
PASS Studies
Post-authorisation safety studies (PASS) are required for most authorised drugs
Drug Utilisation Studies
Drug utilisation studies can form an important part of the risk management plan for a product.
CPRD Studies
CPRD provides unique opportunities for researchers to harness the power of large multi-linked observational datasets.
European Network Studies
Risk Management and Risk Minimisation studies conducted by a network of European countries.
Registries
A patient registry is defined as an organised system that uses observational study methods to collect uniform data.
Flu Vaccine Studies
The DSRU has conducted active or passive enhanced safety surveillance studies on seasonal flu vaccines each year.
Benefit-Risk Assessment
The DSRU team conducts benefit-risk assessments on medicines at the stage of marketing authorisation.
Systematic Reviews
Systematic literature reviews offer a comprehensive overview of a health topic and are often used to make evidence-based decisions in drug safety.
How we work
Our studies cater to both large and small companies.
Our involvement in study design and development depends on your needs.
The DSRU team can work with you to design the best study to meet your requirements, providing guidance on the most appropriate study design or data source to achieve the study objectives. We can also conduct the whole study, handling the entire process from study design to writing the final report.
The DSRU team advises on and conducts studies which are part of Risk Management Plans. In addition, we have experience in conducting studies to monitor the effectiveness of risk management measures.
We also conduct studies to meet other objectives such as addressing regulatory requirements, and understanding the use, effects, and safety of medicines.
Our study package
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