Project Description


Since the early 1980s, the DSRU has undertaken and advised on pharmacovigilance studies both in the UK and Europe. We have extensive experience of conducting a range of pharmacovigilance studies in both primary and secondary care involving General Practitioners (GPs) and specialists, including:

  • case-control studies
  • cohort studies
  • registries
  • database studies
  • surveys

We can advise on all stages of study design and analysis, including

  • writing the study protocol
  • applying for ethics permission
  • interacting with research networks
  • writing the analysis plan
  • analysing and interpreting study results
  • writing the final study report

Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” (WHO). Randomised controlled clinical trials (RCTs) provide a lot of information on safety in selected treated populations under conditions governed by study protocols. However, this information is limited. Further data from post-marketing studies are needed to inform on safety in populations intended to be treated under real-life conditions. Therefore the importance of postmarketing pharmacovigilance cannot be overstated.

Please contact us for an informal discussion

T: +44 (0)23 80 40 86 00

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Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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