Drug Accountability & Reconciliation Tracking (ART™) in Clinical Trials
The drug accountability and reconciliation process in clinical trials is noted for being time-consuming and error-prone, two characteristics that result in it adding significantly to trial costs and timelines.
The onerous task of reconciling discrepancies in supply records that have accumulated over the course of a clinical trial often adds as much as two years to the study closeout phase.
When a work process is viewed as a “necessary evil,” it’s time to innovate. Time to automate. Time to streamline. For the industry’s drug accountability and reconciliation procedures, that time has come.
Almac Clinical Technologies’ drug Accountability & Reconciliation Tracking (ART™) functionality within IXRS® 3 Interactive Response Technology (IRT), does away with the paper records, transcription errors, and multiple systems that lead to missing data and errors. With ART™, you reduce risk to patients, speed trial close-out and prevent the kinds of issues that lead to warning letters from regulators.Find out more
Adding the ART™ functionality to IXRS®3
Support for Risk-Based Monitoring
IXRS® 3 enables the adoption of a risk-based approach to monitoring, providing a drastic reduction in billable hours of costly resources. Site monitors can receive alerts when drug accountability discrepancies appear (for example, if investigational product return counts are not in accordance with drug assignments). Monitors can then immediately access site records and comprehensive reports to remotely assess discrepancies, perform root cause analysis, prioritize and plan site visits and prepare timely remediation plans, if necessary.