Case Study: Using an IVRS to Manage a Multi-Site Supply
Patricia Crabbe, Clinical Supply Manager, Ablynx, a biopharmaceutical company located in Ghent, Belgium shares her experience of implementing an IVRS system.
“We implemented an IVRS system to manage a multi-site supply chain within the scope of a randomized, double-blind, placebo controlled phase I/II study conducted in eight sites spread over three countries.
The IVRS was set up to handle different operational features related to clinical supply as well as to patient management. In relation to the supply chain, there was the option for initial supply or automatic resupply with tracking of shipment status (requested, in transit, received, quarantined, rejected etc…) at any point in time.
At IMP level, each kit status (available, assigned, damaged etc…) as well as drug inventory both at sites and depot could be consulted via the web. Next to this, the IVRS was used to randomise patients and to provide individual dosing information, with constant tracking of patient status and visit management.
A great advantage of having such system in place is that it enhances the streamlining of work flow processes and allows real-time data viewing and interchange via a centralised database. Furthermore it gives you access to integrated reports linking distribution, inventory and patient information. Further introduction of some customised notifications and alerts allows one to be updated at all times.
An important aspect to consider when implementing an IVRS is to plan the set-up early and continously to clearly define the system requirements. This may be very challenging and time-consuming (especially when done for the first time), yet it can save you a lot of trouble-shooting afterwards. In general, the implementation of an IVRS goes together with a relatively high costs, and my experience showed that once the system has been programmed based on the specified requirements, there’s very little flexibility to have things changed without facing additional costs and time.
In summary I could say that the use of an IVRS-mediated supply chain can add value, yet one should evaluate on a case-by-case basis whether the implementation of such a system could be cost-effective or not."