By incorporating barcode scanning of shipments and kits, the ClinPhone® RTSM Mobile App helps clinical trial site staff and CRAs/Monitors accelerate and safeguard supplies arrivals, drug allocation and dispensation, and returns and reconciliation, saving them time and reducing the risk of errors such as incorrect dispensation to patients.
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ClinPhone® RTSM Mobile App
REDUCE SITE ADMINISTRATION, IMPROVE DATA ACCURACY AND ENHANCE PATIENT SAFETY
Clinical trials supplies management at sites typically involves a lot of administrative work using multiple
forms, files and systems to process shipment arrivals (including uploads of temperature data), allocate & dispense to patients, and process returned materials for reconciliation and destruction. These cumbersome processes can lead to delays and the need for manual data entry has the potential to lead to mistakes.
By incorporating barcode scanning and temperature status checks of shipments and kits/packs (terminology is configurable), the ClinPhone® RTSM mobile app helps clinical trial site staff and CRAs/Monitors to accelerate and safeguard supplies arrivals, drug allocation and dispensation, and returns and reconciliation, saving them time and reducing the risk of dispensing incorrect or temperature compromised medication.
(Note: video shows barcode scanning but does not demonstrate the new temperature status check capability)
Upon arrival, a shipment‘s barcode can be quickly scanned using the mobile device’s camera, and site staff can easily confirm the date and time of arrival and note the shipment’s condition.As the individual kits in the shipment are scanned, the app automatically matches them in the system and verifies that the actual medication kits are the same as what was expected.
Temperature data can be automatically read from Bluetooth wireless temperature loggers that are packaged in the kits. Based on the configured temperature profile, ClinPhone RTSM updates the medication status to released/quarantined/damaged, which in turn can trigger automatic ordering of a replacement shipment if necessary.
Allocation and Dispensing
During a patient visit the investigator, pharmacist or study nurse can quickly select a subject, identify which kits to dispense, perform a final temperature read to check that no (cumulative) temperature excursions have occurred while in storage on site, and scan the kits to confirm that they were dispensed to the subject. These steps help ensure that the right kit is dispensed to the right patient and that its safety has not been compromised by temperature excursions. The steps of allocation, dispensing and dosing can be configured to be performed by different users.
Returns and Reconciliation
Returns can be simply processed by the investigator, study nurse or pharmacy staff. Each kit is scanned to identify it, and the user can enter the relevant information about how much of the medication has been used / unused. The CRA/Monitor can follow a similar process to perform reconciliation to verify the returns information is correct and create returns shipments.
Proactive Supply Management with Active Tracking
The ClinPhone RTSM mobile app can be used together with in-pack Bluetooth temperature loggers to provide medication temperature traceability from packaging through distribution and storage (depots and sites) to dispensation to patients. This capability can be provided through PAREXEL’s Active Tracking service for proactive management of temperature-controlled supplies, with our Clinical Trial Supplies and Logistics experts and network of 50+ GMP compliant depots, or through a sponsor’s own or 3rd party distribution network.
Clinical Trial Supplies & Logistics
Randomization and Trial Supply Management
PAREXEL® Informatics provides automated randomization and supplies management through its ClinPhone® RTSM (Randomization and Trial Supply Management) solution. Our services are offered by the industry's most experience and trusted provider of IVR (Interactive Voice Response) and IWR (Interactive Web Response) technologies.