使用 Calyx IRT 优化耗材：限制缓冲液时确保患者供应

背景

Phase III study evaluating the efficacy of 2 different doses of active drug compared with placebo
500 patients
80+ sites participating across six countries
Site stratification

挑战

IMP was very expensive, so ensuring patient supply while limiting overage was critical
Storage of medication was limited for many sites

案例研究

使用 Calyx IRT 优化耗材：限制缓冲液时确保患者供应

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Solution:

Calyx RTSM experts recommended “randomization prediction,” one of our advanced trial supply management options; this sends only the exact medication a site will use for upcoming patient randomization
Traditional IRT solutions base site stock levels on the expected number of randomizations and the amount of medication used for each treatment group
With randomization prediction, Calyx IRT sends medication to each site based on upcoming treatment group assignments known from the randomization list

Calyx RTSM experts worked with the sponsor to understand the expected site recruitment rates and recommended a range of supply strategies including low, medium, and high recruiter

We determined how many randomization list records’ worth of medication would be covered per supply strategy

结果

Randomization prediction ensured a reduction in overage by removing the buffer
The stock required to be shipped to the site was reduced, as shipments contained specific medication for randomization assignments
Patients had the right drug at the right time

Randomization Prediction

Randomization prediction is one of Calyx IRT’s advanced trial supply management options; a flexible approach that can be tailored to specific protocol requirements & supply criteria.

If your study stratifies by site, Calyx IRT can send IMP to each site specific to upcoming treatment group assignments; this ensures overage is reduced.