Clinical Trial Material Management

IVRCC’s Automated Supply Management Enables the Sponsor to Manage Supply with Less Work and Better Inventory Control

Global studies may involve many countries and many sites, making supply management a complex and labor-intensive process.

The activation of a site allocates a pre-determined initial allotment of study drug or devices automatically via our supply management solution. Clinical Trial Material on-site is often required as a factor for site initiation visit sign-off.

IVRCC systems generate automated inventory reports, and subsequent shipments can be facilitated based on the estimated or actual need for additional supplies at the sites or distribution centers.

IVR Clinical Concepts Interactive Voice Response Systems (IVRS) and the CTM Supply Chain

Our integrated IVRS and IWRS can provide full visibility of patient drug or device kits. When a site confirms receipt of kit numbers to the IVRCC system, it provides real-time visibility of what has been received and shipped. Allocation of specific kit numbers to patients at dispensation visits allows for stock subtractions, providing accurate inventory of all material or devices remaining at each site.

The inventory is maintained, added to, or redistributed.  This enhanced visibility allows minimum stock levels and resupply on a “just-in-time” basis. IVRCC’s IVR/IWR systems can greatly reduce the waste of clinical trial material caused by overstocking of sites. Integration of IVRS/IWRS with distributor shipping systems automates the entire ordering and verification process.

IVRCC’s IVRS improves reporting of drug accountability. Monitors no longer perform accountability during site visits using paper-based systems. You no longer have to track returned or unused medication and devices to what a site received manually.

IVRCC can develop user-friendly phone and web-based systems that provide a full list of material shipped to the site, against which accountability data can be entered directly.  If returned or leftover medication is destroyed locally, destruction of the medication can be confirmed into the system. Alternatively, if medication is sent to a specialist contractor for verification and storage prior to destruction, this can also be captured by the system.

Clinical Drug Supply Management with Unblinding Capabilities

• IVRCC utilizes this function to maximize use of limited and expensive drug supplies and allow treatment to be unblinded for adverse experiences. This function is utilized to blind open-label supplies, to randomize patients according to code, and to confirm proper assignment through hospital pharmacies.
• Any data collected by the IVR/IWR systems is integrated with other electronic clinical systems, making user-friendly collection of data easily transferrable to the final database.
• Automated alerts are programmed into these systems by IVRCC, via IVRS and/or IWRS, to notify any clinical trial personnel involved (sponsor, project managers, site monitors, site coordinators, CTM distributor/depot, pharmacists, etc.)
• Critical restock inventory points are programmed and alerts are directed to the designated addressees for automated, dispensation and resupply, inventory control of critical CTM.