To determine the time spent on reconciling supplies, resolving discrepancies, and completing close-out activities, Almac Clinical Technologies – a member of the Almac Group – surveyed clinical trial personnel involved in the accountability and reconciliation process.
The research compared manual paper-based processes against electronic, as well as a hybrid approach of both.
According to the report, automation, on average, reduces time spent when reconciling supplies by 87%, or approximately 32 minutes per drug kit. It also cuts the time spent per trial on close-out activities and reports as it pertains to accountability and reconciliation by 35%.
Additionally, because it reduces the amount of time monitors spent at clinical sites to complete various activities, the report suggests a further average savings of $435,456 per study.
Almac estimated automated drug accountability and reconciliation systems can in total save a company a minimum of $1.3m per trial in tangible costs.
Matthew Cocking, marketing director, Almac Clinical Technologies, said the results were surprisingly positive. “The data revealed a drastic decrease in time and effort spent on this area as a result of utilizing an electronic solution for drug accountability and reconciliation,” he told us.
“We view the results of this as very positive for everyone involved in these areas of clinical development. By employing an automated solution for drug accountability and reconciliation, the evidence is clear that this approach will provide meaningful cost-savings to sponsors and CROs during the course of a clinical trial,” said Cocking.
As Cocking explained, if the data are not logged accurately, the drug accountability and reconciliation processes may “inevitably result in lengthy investigations, often delaying study closeout.”
He added, “Furthermore, as some clinical sites still employ a paper-based approach as part of their standard operating procedures, we view this data as a great incentive to collaborate with trial-sponsors to work together towards updating their processes in order to reduce the burden on site coordinators as well.”