Optimizing Supplies with Perceptive IRT: Ensure Patient Supply while Limiting Buffer
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Situation
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
Challenge
IMP was very expensive, so ensuring patient supply while limiting overage was critical
Storage of medication was limited for many sites
Solution:
Perceptive 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, Perceptive IRT sends medication to each site based on upcoming treatment group assignments known from the randomization list
Perceptive 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
Result
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 Perceptive 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, Perceptive IRT can send IMP to each site specific to upcoming treatment group assignments; this ensures overage is reduced.
Additional Features
— Can also cover medication needs for the next visit; beneficial if the next dosing visit is close to randomization
— Can be used with another stratification factor, in addition to site
— Does not require sites to have all types of medication for a randomization to proceed
— Can be combined with standard buffer & prediction strategies
