The DSRU team has extensive experience and can offer a broad range of support and guidance in all areas of pharmacovigilance, tailored to your needs, including the following:
- Supporting companies to handle regulatory enquires
- Provide advice on addressing regulatory PV questions by conducting Benefit/Risk evaluations, proposing aRMMs where necessary, and suggesting PASS studies if appropriate
- Provide consultancy on epidemiology, risk management, and risk minimisation to all organisations
- Medical writing support for protocols, reports, and responses to regulators
- Provide epidemiology, risk management, and risk minimisation services for companies who do not have these functions internally
- Provide study management support and monitoring regulatory compliance
- Providing clarity on post-Brexit pharmacovigilance responsibilities in the UK
- In-house training
We can advise
Since the early 1980s, the DSRU has undertaken and advised on pharmacovigilance studies both in the UK and Europe.
We can advise on all stages of study design and analysis, and frequently conduct pharmacovigilance studies in both primary and secondary care, using a range of study designs.