Required Non-Investigational Materials
It doesn’t seem like a big deal until you have to do it – managing the bandages, syringes, saline solution, tubing, and so on, that Sites may require during the conduct of your clinical trial. The non-investigational materials required for use at clinic visits are often regarded as ‘no-brainers’, not demanding much forethought or attention. But it takes only one or two experiences in a complex trial for Clinical Project Managers (PMs) to concede that developing and managing processes for ordering, reordering, controlling limits on the amount ordered, and managing the users authorized to order supplemental materials is an important part of the efficient – and painless-- execution of a clinical study.
Inventory Cost-effectiveness, waste control, and efficient timing of resupply are all critical components of a well-oiled clinical trial process. And this is where IRT (IWR/IVR) systems shine! With Veracity Logic’s flagship VLIRT® system, it’s an easy matter to add supplemental materials to an at-a-glance inventory for each study site, at no additional cost to IRT startup and maintenance. The VLIRT® system permits PMs to set baseline, maintenance and alert levels of supplies, to configure resupply algorithms, to modify both algorithms and limits as study needs require throughout the trial. Shipment schedules can be configured to meet the best cost/waste strategy.
Alternately, the system can be configured to permit ‘on demand’ manual requests, allowing sites to request items when needed, in amounts controlled by study design. User roles authorized to manage and monitor these activities can be reconfigured as needed throughout the study.
Veracity Logic’s system also offers an add-on module that enables program managers to use the system to centralize the ordering and handling of ancillary supplies, i.e., supplies that do not need to be part of site inventory control. VLIRT® is a still a good way to simplify site activities in this important area of clinical supply.
Other topics in this month's newsletter:
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