Almac Group Publishes Comparison Report on Automated vs Paper based Accountability & Reconciliation

April 8, 2019

Cost analysis findings include savings of over $1 million per trial

Souderton, PA, USA,  8 April 2019 – Almac Clinical Technologies, a member of the Almac Group, has today 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 sponsors and sites 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.


About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

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