How does DSRU Consultancy work?
The DSRU Consultancy has a small flexible team of epidemiologists, clinicians and pharmacists. Watch this short video to find out how DSRU Consultancy provides advice in pharmacoepidemiology, pharmacovigilance, risk minimisation and risk management.
We can provide one-off or ongoing advice or we may give advice that leads to provision of a full study service. We also provide a special consultation service to smaller companies.
Working with DSRU consultancy may involve these steps:
Understanding the safety issue: We develop a full understanding of the safety issue by meeting with you to hear your requirements, finding out about the product and the stage it has reached in the product lifecycle and looking at any regulatory communications and requirements. We have a deep understanding of pharmacovigilance regulations and many years’ experience of interpreting regulatory requirements.
Advising on optimal study design and data source: We determine the best study design and the data source by examining the nature of the study population, the extent to which the product is used, how common the safety outcome is and whether retrospective or prospective data collection would best answer the research question.
Determine who does what: We will work with you to decide which division of labour would suit you. You may receive advice from us on what the best study would be then undertake the study in-house or with another provider. However in many cases, following provision of advice, we are asked by the company to undertake the study ourselves, using either in-house data sources or external data sources, such as CPRD.
The initial consultation is free! Watch this video to find out more or get in touch to discuss your enquiry (with no commitment): Dr Liz Lynn, Head of Scientific & Educational Development, email@example.com