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 total control and visibility into the entire chain of custody down to the individual IMP unit level. This improves trial oversight, reduces dispensation errors and strengthens 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. This process, when not supported by automation, is onerous and error-prone.
“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,” said 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 have 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.”
ART is designed around a consistent and intuitive workflow across the full spectrum of the trial, providing insights on a single screen.
“For ART to be effective, it had to be easy for users up and down the supply chain to use,” said Higgins.
“We have ensured that the solution supports, rather than detracts from, their daily work. The addition of this native functionality to Almac’s existing IRT solution will help sponsors and CROs realise time savings, improve site compliance, reduce risk to patient safety, and safeguard against trial delays.”
Importantly for sponsors, ART is fully configurable. It can be deployed quickly with minimal time, regardless of the trial’s complexity, size or the design of the IMP.
