TECHNOLOGY AND INNOVATION
must be within “floor” and “ceiling” stock levels, Coxon points out. For example, if the supply reaches the floor number, the IRT can be triggered to ensure the site goes back up to the ceiling level, he explains. A floor number is necessary as drugs can be damaged during transit or fall out of the temperature range. Forecasting errors can expose trials to
supply issues. For instance, there can be overstock at sites or they may not have room to store extra supply, which can lead to waste, management approach labels and dispatches drug supply when needed, but it does not randomise patients and uptake is yet to peak.
Forecasting not straightforward Studies often throw curveballs that test the forecasting methodology. It can be tough to predict the recruitment pace, which varies among sites and countries, Wanninayake says. Forecasting is more complex if a trial Townsend adds. “There needs to be enough stock sent for any eventuality,” she notes. There are more physical locations and
accompanying logistics to consider with large depot may be supplying the investigational
there can be different depots for different countries. In some cases, the sponsor provides the comparator drug for one country, while other sites must source the drug themselves. But Mooney underscores it is not about trial
size. “It is [about] when and where patients decide to show up,” he adds. “IRT planning should consider patients you don’t know about.” For example, drug supply could be Hence, there is a need to have a floor stock level, he adds. An effective IRT can marry the predictable and unpredictable sides of managing supply, Wanninayake says. “An effective IRT can be trial is going.”
There are two ways to develop an IRT: “out of to match the study design, and completely customised IRT systems. is straightforward and can be as easy as ticking a box so the number of site visits in the
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