Built for Purpose IRT: Drug Supply Support for Complex Environments
Navigating today’s clinical trial landscape requires a flexible and innovative approach to IRT. Now more than ever, IRT must afford sponsors, sites, and patients flexibility in executing life-saving clinical trials. For the modern trial, IRT study design must absorb changes to cohorts, visit schedules and dosing schema – all while providing optimization support for drug resupply strategies that pivot on a weekly or daily basis.
During a recent interview – Cenduit’s team of drug supply experts discussed how Cenduit’s industry-unique IRT technology benefits both sponsors and sites.
Question 1: Can you give us a recent example of cost savings Cenduit IRT interjected into a sponsor’s supply strategy via our optimization tools.
Developing strategies for the management of buffer stock at sites is a common pain point for Clinical Research Associates and Clinical Supply Chain Managers alike. Standard IRT supports a variety of supply strategies, then applies them to sites based on predicted enrollment. The issue that tends to ensue, is that enrollment, very often, differs from what has been forecasted, leaving sites with unsuitable supply strategies.
When sites over or under enroll, this results in too little or too much Investigational Medicinal Product (IMP) shipped. To mitigate this, Cenduit has developed a resupply optimization tool – Dynamic Optimal Buffer Stock. Before enrollment, multiple supply strategies are generated; from there, this tool will assess actual patient activity, and changes the resupply strategy automatically as required. This ensures sites only receive necessary quantities of IMP, resulting in less drug waste, fewer shipments, and ultimately – savings.
Recently, a large, multinational client applying Cenduit’s Dynamic Optimal Buffer Stock Tool has already seen a 35% reduction in the need for a costly comparator and has reduced the projected number of shipments by 12%.
Question 2: Can you describe way in which Cenduit’s drug supply technology delivers efficiencies at the site and sponsor level?
IRT generally allows a view into a few variables when determining what needs to be shipped for upcoming visits and resupply – one of these being site stock. The industry standard is to manage the expiry date of IMP at the lot level. This method prohibits the IRT from triggering the shipment of some kits to sites that may be suitable for upcoming visits. In addition to this, standard IRT will unnecessarily replace material at sites. Cenduit is taking a more granular approach to resupply by allowing the management of stock expiry at a patient and visit level.
Cenduit’s IRT enables the dispensation of kits based on expiry information down to the actual patient visit level, coupled with automated buffer stock calculations based on the shortest expiry. Therefore, only usable IMP is shipped, and shipments are maximized by including multiple lots of the same kit type in a single order. This functionality within Cenduit IRT reduces unnecessary shipments and drug waste, all while ensuring sites have the right drug for the right patient at the right time.
Question 3: Can you describe another benefit that being able to view drug expiry dates at the kit level brings to a trial.
Cenduit IRT’s expiry management functionality delivers significant benefits when a study has varying visit durations. When one kit type is being used for all visits, standard IRT will set the expiry parameters based on the longest visit duration. This will prohibit the IRT from shipping material for upcoming visits, despite the expiry date being sufficient, until after the visit end date. As an alternative to this method, some sponsors will use different labeled kit types to represent variable visit durations. The problem with this, however, is that the initial labeling of the kits requires clinical supply to guestimate how many of each kit type will be used.
For the sake of this example, let’s suppose that a study has visit durations of one month and four months. If too many four month kits are created, they will have to be delabeled and then relabeled appropriately for dispensation as one month kits.
Cenduit’s IRT permits the use of a single kit type along with the information on kit expiry dates needed to manage IMP more efficiently. The use of a single kit type in a study with varying visit durations greatly maximizes the use of IMP while also allowing for continuous shipments from depots for visits of shorter durations.
Question 4: Shipment costs are a significant aspect of the drug supply budget. Describe innovative technology built into Cenduit IRT that helps sponsors save on shipments.
Cenduit has recently implemented an IRT parameter we call “Global Look Ahead.” This feature allows for the replacement of expiring kits in orders raised prior to the “start replacement date.” If the system determines that an order is required, and Global Look Ahead is used, the IRT will not include kits on site with the expiry date pending, even though the “start replacement date” has not been met. This results in the replacement of kits with upcoming expiry, so once the “start replacement date” is met, many sites will have already had expiring kits replaced, eliminating the need for an additional shipment.
Along with our sophisticated approach to expiry date management, this empowers Cenduit to deliver significant savings by reducing unnecessary shipments, all while reducing the burden on sites and depots
Question 5: Can you provide a practical example of how the Global Look Ahead functionality introduces savings for our sponsors?
Cenduit’s Global Look Ahead parameter allows sponsors to maximize shipments raised due to patient activity, by proactively replacing kits soon to expire. After the desired timeframe for Global Look Ahead is established, this functionality runs automatically. Once the set parameter is implemented, any site that raised orders prior to the “start replacement date” will no longer require a shipment once that date is met. The impact this has will differ from client to client, trial to trial, and site to site, but there is significant opportunity for savings on shipment costs.
If you’re interested in learning more about Cenduit IRT or our drug supply optimization tools, click here or reach out to us on the “Contact Us” page of our website. We look forward to partnering with you.
