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

  • managing studies undertaken by another provider
  • 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.

DSRU Consulting is providing pharmacovigilance services and oversight on behalf of the MAH for 4 ongoing Post-authorisation Safety Studies (PASS) and Drug Utilisation Studies (DUS) conducted by other providers. This comprises many tasks, including the following:

  • Provision of  post-marketing pharmacovigilance services
  • Oversight of ongoing PASS and DUS on behalf of MAH
  • Scientific support
  • Study management
  • Monitoring regulatory compliance
  • Statistical support
  • Medical writing support for protocols, reports and EMA responses
  • Data management oversight
  • Pharmacoepidemiology support

Please Contact Us if you would like to find out more or think this service could be of interest to your organisation.

Please contact us for an informal discussion

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

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