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Almac Expands IXRS 3 IRT Platform

10.24.17

Adds Accountability and Reconciliation Tracking (ART)

Almac Clinical Technologies has extended the functionality of its IXRS 3 IRT platform to include Accountability and Reconciliation Tracking (ART). 
 
ART captures all accountability data relating to the assignment, dispensation, and return of investigational medicinal products (IMP) throughout the course of a clinical trial. The toolkit provides control over and visibility into the entire chain of custody down to the individual IMP unit level in an effort to improve trial oversight, reduce dispensation errors, and strengthen patient safety. 
 
To conform to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) sponsors must be able to prove that the IMP administered to patients was in a safe condition and that it was used only by subjects and according to the prescribed dose. All unused IMP must be accounted for at the end of the trial, and any discrepancies in records must be documented and explained. ART automates and aims to improve this process.
 
“Many trial sponsors inadvertently allow discrepancies in the accountability and reconciliation process to accumulate until the end of the trial due to paper record keeping or data accumulation from disparate sources,” explains Valarie Higgins, president and managing director of Almac Clinical Technologies. “So what was at best a laborious task becomes a herculean effort that often adds as much as two years to the study close-out phase. We’ve found that by building error-prevention checks into a completely digital workflow, post-study reconciliation can be essentially eliminated. Trial Sponsors can close out their studies quickly and move forward with submitting their data packages for approval faster.”