Overview
DSRU Consultancy offers advice and support on all stages of pharmacoepidemiological study design and conduct.
Our multidisciplinary team of pharmacoepidemiologists, clinicians, research scientists, and regulatory experts can advise on studies to meet regulatory requirements, ensuring they meet our quality scientific standards. We are able to assist with study design, or carry out the study as needed.
Meeting your requirements
We can advise on the most appropriate study methods and data sources that meet your requirements.
Data sources may or may not be DSRU sources, but will be the best source to meet your requirements.
Our studies can be designed to:
- Examine drug utilisation in real life settings (use, effects/effectiveness, and safety of products)
- Examine potential risks, identified risks, and missing information as outlined in a product’s Risk Management Plan
- Study the overall safety profile of a medicinal product
- Examine safety signals identified from spontaneous reporting or other sources
- Define disease burden in terms of prevalence, incidence, cost, disability, and potential complications
- Examine patient demographics, characteristics, and risk factors
- Identify and examine patient outcomes
Study Designs
We are experienced in the application of a wide range of pharmacoepidemiological analytical methods and can advise on all aspects of study design and methods.
These include:
- Non-interventional observational studies of all designs (e.g. cohort studies and case-control studies)
- Self-controlled study designs
- Time-series methods
Data Sources
The DSRU has experience in using a broad range of data sources for pharmacoepidemiological research, and can advise the best resource for your needs.
These data sources may include:
- Primary data collection from patients and prescribers
- Secondary data collection
- Electronic health records (e.g. Clinical Practice Research Datalink [CPRD])
- Drug and Disease registries (both in-house and external)