Randomization and Trial Supply Management

Reclaim time with the inherent automation capabilities, and gain true visibility into the end-to-end patient journey

Gone are the days of logging into separate systems to randomize patients or manage trial supply. TrialKit’s RTSM is a modern, purpose-built solution that is seamlessly integrated within the entire TrialKit platform, allowing you to increase efficiency, decrease risk, and optimize trial supply.

Reclaim time with the inherent automation capabilities, and gain true visibility into the end-to-end patient journey.

Randomization

Powerful, yet simple patient randomization that is aligned with the trial protocol
Stay on top of randomization activities with inherent automation capabilities and notifications

Quickly and accurately randomize patients. And, for ultimate convenience and productivity, use either the web or mobile app to perform randomization and execute mid-study protocol changes.

  • Randomize by any trigger event
  • Stratify randomizations on any system variable
  • Centralize or stratify the randomization schedule by site
  • Randomize a patient multiple times per study
  • Perform blinded or unblinded randomization
  • Reassign tailored randomization IDs based on allocation
  • Import the randomization schedule from Excel
  • Set up customizable and automated notifications (push and email)

Inventory Management

Because our inventory management is tightly integrated with the same database as the study data, you benefit from an automated workflow and reduced time and cost.

When a site is activated, the system picks inventory items based on the predefined site ceiling.
The distributor and site are notified of the items to expect, their lot, item number, and expiration date.
The system informs the distributor to ship the allotted items to the site.
When the items are received, the site logs their receipt in the system.
These items become available for study participants.
When site inventory hits the predetermined floor level, the product is automatically reordered based on the inventory available at the distribution center.
Manual override functions are also provided to move products between sites due to overstock or back to the distributor for proper disposal.

Stay up to speed on inventory movement with comprehensive reporting and notifications

Reports
  • Generate a comprehensive breakdown of each drug’s full history from the time of order with the distributor to patient assignment
  • Show all products and their current location using the inventory disposition report
  • Proactively move products around based on the whole study overview of product distribution and trends
  • Drill down to granular details such as for a specific supplier, patient, or site
  • Easily view site rejection of inventory (e.g. shipment not received, item damaged, overstock)
  • View an audit history of all system-generated emails for administrative oversight of automation - useful for distributors to maintain their own inventory systems
  • Automatically generate status reports: inventory at a site or audit history on a per item basis
  • Set notifications for user-defined events, e.g., if a site reports more than three missing items in shipment
  • Use custom workflow configurability to include the manufacturer, supplier, depot, site, and participant
  • Automate communication with distributors, who do not log into the system
Notifications

Additional Features and Functionality

  • Assign quantities from inventory on a per participant basis (e.g., based on sex or weight) using data points from the participants’ records
  • Create and print barcodes for products
  • Directly scan any product using the device camera and update inventory instantly
  • Set up and assign specific sites to multiple global distributors
  • Return product to supply
  • Scan barcodes directly into an eCRF and autofill data from the FDA device registry
  • Manage inventory from the mobile app - at both the site and administrative study levels
  • Use administrative approval to maintain regulatory controls on which distributors are able to ship products
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