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 moreAdding the ART™ functionality to IXRS®3
Protects patient safety
Real-time validation checks throughout all medication-related events and visibility into the condition of drugs throughout the supply chain reduce the opportunity for patients to be given the wrong or unsafe medication.
Reinforces Compliance
Because the software captures both the drug assignment and details on the investigational product that is administered to the patient and subsequently returned, it serves as an extra step to ensure that the patient followed the protocol. Non-compliance is reduced and highlighted.
Minimizes Risk
Capturing drug accountability and reconciliation information in the IRT, eliminates transcription errors, and the challenges and inaccuracies that stem from paper processes. Compliance is improved and risks to the trial are greatly reduced.
Improves completeness and accuracy of accountability data
The system guides site users through the process of documenting returned investigational product (used, unused, missing and damaged). Users are “forced” to complete all of the required fields, and logic checks prevent data entry errors.
Speeds study close-out
When used as the primary method for accountability data capture and reconciliation, IXRS® 3 prohibits users from entering erroneous data which prevents discrepancies from occurring and greatly reduces time spent on drug reconciliation during the closeout phase.
Streamlines operations/reduces costs
The tedious and time-consuming steps in reconciling discrepancies that appear in paper or on multiple systems are all but eliminated. Site monitors can use their time more productively, focusing their attention on potential problem sites/procedures, saving time.
Clinical Operations
Clinical Operations
Clinical Operations
ART™ is a completely configurable solution for drug accountability and reconciliation that conforms to any protocol – giving you complete control over sites’ compliance with Good Clinical Practice (GCP). Real-time error prevention and traceability of clinical supplies means that at study closeout, reconciliation is a mere formality. Say goodbye to lengthy delays in sorting through discrepancies, correcting errors, and chasing missing information.
Intuitive workflows within IXRS® 3 give users access to comprehensive features designed to improve compliance, minimise errors, ease frustrations, and save time and money.
BackSupply Management
Supply Management
Supply Management
Almac’s drug accountability and reconciliation for clinical trials paperless chain of custody user interface provides real-time traceability of clinical supplies as the study progresses, making compliance with GMP routine and drug reconciliation and at study close a mere formality. For Supply Managers, the tool provides:
• Full Traceability, On-Demand Assessment. Supply Managers have 100 percent visibility to supplies throughout the clinical supply chain, at any point in time. A barcode-enabled platform provides reliable traceability of supplies as they move through the clinical trial, recording their whereabouts and condition.
• Immediate Drug Reconciliation Capabilities at the Depot. The system guides site users through the process of managing and documenting returned IP (unused, damaged, or expired drugs and empty containers), forcing them to complete all of the required fields. Logic checks prevent basic data entry errors so that the information passed on to depots is cleaner and more complete than what is delivered via paper-based systems, allowing depots to close their records at once. When depots receive returned shipments from sites, they can easily compare the kit contents to the full drug accountability details provided in the shipment manifest.
• An audit trail. At any time, users can access a complete and auditable trail of the physical chain of custody for all clinical supplies. These records can be produced for auditors, indicating that 100 percent of lots and returned shipments were successfully destroyed.
BackSupport 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, prioritise and plan site visits and prepare timely remediation plans, if necessary.
Related Resources
Publication
ART™ – Automated Drug Accountability: Maintaining a chain of custody from release to destruction
Find out more
White paper