Following a regulatory audit, a large pharmaceutical client had 1.2m documents that needed reviewing to identify adverse events. Regulations gave nine months to do this and the client estimated they would find adverse events in around 2% of the documents. These could then be captured through their standard case processing of serious and non-serious events.
Ashfield Pharmacovigilance, whose services are delivered by Ashfield company Drug Safety Alliance, significantly expanded the client’s team of case managers to cope with the ten-fold increase in volume. As well as setting up IT configurations and office space we trained the project team, established key performance indicators to make sure cases were handled quickly and conducted progress meetings.
During the project, we found some products had a higher rate of adverse events than anticipated – as high as 22%. We were able to respond quickly because we’d established a flexible project team, with additional support available as needed. As a result, we reviewed over 110,000 documents per month, dealt with 2,200 potential adverse cases per month and completed the project on time.
How this helped patients
Our work on this important project enabled patient data to be handled efficiently and quickly. This will ultimately ensure that the client meets its regulatory obligation and the client’s products can remain available for patients.
Reflecting our values
• Partnership: We worked closely with our client, creating a strong, solid partnership.
• Quality: Our team provided a quality service, meeting deadlines despite hugely increased workload.
• Expertise: We had the expertise to plan, coordinate and deliver an exceptionally effective project.