Almac Group Publishes Report on Automated vs Paper based Accountability


Applied Clinical Trials

Almac Clinical Technologies, a member of the Almac Group, has published a report which finds that the use of an automated chain-of-custody system can save a minimum of $1,300,000 per clinical trial in operating costs.

The drug accountability and reconciliation processes are noted for being time-consuming and error-prone, two characteristics that result in contributing significantly to clinical trial costs and timelines. The onerous task of reconciling discrepancies in drug supply records which can accumulate over the course of a trial often adds significant delays to the study close-out phase.

The implementation of drug accountability & reconciliation software eliminates paper-based records, transcription errors and multiple systems that lead to missing data and errors thereby reducing risk to patients, speeding trial close-out and preventing non-compliance errors throughout a clinical trial.  However, the assumption has always been that automation can also cuts costs.

In order to quantify this assumed value, Almac Clinical Technologies sponsored a survey of clinical trial personnel involved in the accountability and reconciliation process to determine the time spent on reconciling supplies, resolving discrepancies at sites and completing close-out activities.  The research compared trial sponsor companies using manual processes against those using electronic (including those applying a hybrid combination of both paper & electronic) processes.

The results reveal that, on average, automation reduces time spent when reconciling supplies by 87% (32 minutes) per drug kit, whilst trimming time spent on close-out activities & reports pertaining to accountability & reconciliation by 35% per trial. Additional average savings of $435,456 per study are made by reducing the time that study monitors / CRAs would be required at clinical sites in order to complete accountability and reconciliation activities.

In total, the survey established the use of an automated drug accountability & reconciliation system can save a company a minimum of $1,300,000 per trial in tangible costs.

Valarie Higgins, President and Managing Director of Almac Clinical Technologies, comments, "This research not only highlights the key benefits of using an automated drug accountability and reconciliation system compared to a traditional paper-based approach, but also the significant cost savings that could be achieved.  We, at Almac, appreciate these finding are incredibly valuable to trial sponsors who are currently considering such an approach and we would be delighted to advise and support companies during this process.” 

To read the report and find out more about Almac, visit here.

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