veracity logic clinical trial material management
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Clinical Trial Material Management
Veracity Logic, LLCMark Paul, Managing PartnerPhone: +1-919-225-7850Email: [email protected]
Clinical Trial Materials
About UsThe Veracity Logic VLIRT® system is an innovative, fully configurable, and customizable InVentory Randomization System (IVRS) designed to meet your clinical study requirements. Our validated 21 CFR Part 11 compliant system provides Subject Management, Clinical Supply Management, Site and Role based Data Access, Alerts and Messages, and On-Demand and Scheduled Data Exports.
Automatic and PredictiveOur clinical supply management model provides automatic and predictive clinical supply methods, manual and automated drug shipments, batch and expiry management, tracking and returns.
11312 US 15 501 Hwy North Suite 107151 Contact: Mark PaulChapel Hill, NC 27517 Email: [email protected]
Clinical Trial Materials
VLIRT contains an extensive suite of tools for managing clinical trial materials (CTM) during the course of a study. The suite includes tools for managing batches, regions, sources of clinical trial material, shipments to regional depots and clinical sites, drug accountability and managing both individual and bulk kits.
Shipment ManagementVLIRT tracks the status of the study's supply chain: shipments from the warehouse to regional depots (if used) to clinical sites and back. Shipments are requested through the system; the request is sent to the warehouse or depot assigned to fulfill the request. After packing kits to satisfy the request, distribution personnel will indicate in the VLIRT system that the shipment has been sent to the requesting site. When it arrives, site personnel will record the shipment as received and, assuming there were no problems with kits in the shipment (such as damage during transport), the kits are made available for assignment to subjects. Shipments made from sites back to depot or warehouses are similarly managed by the system.
11312 US 15 501 Hwy North Suite 107151 Contact: Mark PaulChapel Hill, NC 27517 Email: [email protected]
Shipment Requests
11312 US 15 501 Hwy North Suite 107151 Contact: Mark PaulChapel Hill, NC 27517 Email: [email protected]
VLIRT includes three standard methods for requesting shipments for a site – Manual, Static, and Predictive. Each site can be assigned to one request type; users are not limited to a single method of requests for all the sites in study.
•Manual An authorized user who is un-blinded can request the desired number of each type of kit to include in the shipment request for the site. VLIRT will not automatically generate a shipment request for sites assigned to Manual resupply.
•Static Each evening VLIRT checks the inventory of each kit type at each site. When any kit type reaches a set Alert Level, a shipment request is generated for that site. The shipment request includes a sufficient number of kits to raise the site inventory of each kit type to an established Baseline Quantity. The Baseline Quantity and Alert Level may be changed during the course of the study to reflect the number of subjects seen at each site.
•Predictive As in the static inventory model above, each evening VLIRT checks the inventory of each kit type at each site. When any kit type reaches a set Trigger Level (based on the number of subjects active in the study, enrollment rate, and the number of days of inventory), a shipment request is generated for that site which includes a sufficient number of kits to raise the site inventory of each kit type to the established Target Level quantity (again based on desired number of days of inventory). The trigger level and target level number of days can be set for each site along with other site-specific variables to assist in reducing the number of shipments and wastage of clinical trial material at each site.
Temperature Deviation Mgmt
11312 US 15 501 Hwy North Suite 107151 Contact: Mark PaulChapel Hill, NC 27517 Email: [email protected]
Temperature Deviation (Excursion) ReportingVLIRT includes options for tracking shipments which experience a temperature deviation during transport from a warehouse or depot to a site. This option is used when clinical trial material must be maintained in a refrigerated or frozen state during transport. When receiving a shipment, users will indicate whether the shipment experienced a temperature deviation and which kits were affected. These kits are given a status of Temp Deviation and will not be assigned to subjects during the study.
Kit ManagementVLIRT provides authorized users the ability to view a list of kits located at their site(s) and take certain actions with those kits. Authorized users are able to report a problem with an individual kit (such as one that has been damaged, lost, or is unusable for some other reason), report a kit that was misadministered, and report a kit experiencing a temperature deviation (for studies using temperature controlled storage).
Drug Accountability
11312 US 15 501 Hwy North Suite 107151 Contact: Mark PaulChapel Hill, NC 27517 Email: [email protected]
VLIRT provides tracking of kit returns to the clinical site and return shipments to a regional depot or central warehouse. The system tracks the number of units used from a kit (as reported by the subject) and the number of units returned with the kit; the system calculates the number of units not accounted for. This information is available in real-time for site monitors as they prepare to visit their sites.
Inventory Report
VLIRT provides an inventory report to un-blinded users that allows them to determine an exact count of the number of CTM of each type at each site in the study. The report shows the number of kits On Order (including those in transit from a warehouse or depot), the number Available at each site, the number Assigned to subjects at each site, and the number that are Unavailable at each site. A sample screenshot is shown below.
11312 US 15 501 Hwy North Suite 107151 Contact: Mark PaulChapel Hill, NC 27517 Email: [email protected]
Inventory Report (continued)
The count of Unavailable kits includes those kits having statuses of Returned, Misadministered, Damaged, Missing, Unusable, Temp Deviation (for studies requiring CTM to be refrigerated or frozen), Expired, and those kits that are within the defined expiration window (Expiring). The screenshot below expands the Unavailable category.
11312 US 15 501 Hwy North Suite 107151 Contact: Mark PaulChapel Hill, NC 27517 Email: [email protected]
Allow Us To Provide A Demo
Veracity Logic, LLCMark Paul, Managing PartnerPhone: +1-919-225-7850Email: [email protected]